Weck
Hemolok Medium Large Clips 3/CARTRIDGE 42/BOX
4manufacturers in China registered for this device type
321catalogue numbers in this listing
7510(k) clearances naming this product code
18recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133202 |
| Record published | 2023-10-26 |
| Record revised | 2025-09-26 (version 25) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 12, box of 12, box of 48, box of 14, box of 20, box of 10 |
| Sizes | Height 1.91 to 13.84 mm; length 2.24 to 12.71 mm; depth 0.06 to 0.15 in; width 0.3 to 0.7 in; length 0.45 to 0.78 in; length 35 cm; outer diameter 10 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN928808 | 3 | In distribution | |
| IPN920962 | Length 5.79 mm | 10 | In distribution |
| IPN008593 | Height 2.67 mm | 25 | In distribution |
| IPN914930 | Height 10.07 mm | 24 | In distribution |
| IPN028158 | Length 12.6 mm | 10 | In distribution |
| IPN008935 | Length 12.6 mm | 10 | In distribution |
| IPN008501 | Length 5.79 mm | 25 | In distribution |
| IPN008654 | Length 5.79 mm | 25 | In distribution |
| IPN028140 | Length 5.79 mm | 25 | In distribution |
| IPN931020 | Length 2.24 mm | 6 | In distribution |
| IPN028137 | Hemoclip Traditional Small Ligating Clips, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN028147 | Length 12.71 mm | 10 | In distribution |
| IPN008586 | Length 3.55 mm | 10 | In distribution |
| IPN915182 | Hemolok Medium-Large Ligating Clips, Polymer | 6 | In distribution |
| IPN008663 | Hemoclip Traditional Medium Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN915186 | Hemolok Xtra-LargeLigating Clips, Polymer | 6 | In distribution |
| IPN920947 | Height 2.75 mm | 25 | In distribution |
| IPN002006 | Horizon Medium Ligating Clips, 4-Pack, Titanium | 24 | In distribution |
| IPN008665 | Height 2.67 mm | 10 | In distribution |
| IPN002005 | Horizon Medium Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN008667 | Length 9.27 mm | 10 | In distribution |
| IPN920969 | Height 9.3 mm | 6 | In distribution |
| IPN915124 | Length 5.8 mm | 10 | In distribution |
| IPN002010 | Length 8.98 mm | 24 | In distribution |
| IPN028170 | Length 3.68 mm | 6 | In distribution |
| IPN028145 | Length 3.55 mm | 10 | In distribution |
| IPN915201 | Length 35 cm | In distribution | |
| IPN027367 | 6 | In distribution | |
| IPN008535 | Hemoclip Traditional Small Ligating Clips, Non-Sterile, 25 Clips/Cart, Tantalum | 25 | In distribution |
| IPN008649 | Hemoclip Traditional Medium-Large Ligating Clips, 16 cart/box, Stainless Steel | 10 | In distribution |
| IPN920949 | Hemoclip Plus Small Strongpoint Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN028154 | Height 2.69 mm | 10 | In distribution |
| HOL2LG | In distribution | ||
| IPN008589 | Hemoclip Traditional Large Ligating Clips, Non-Sterile, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN027366 | 6 | In distribution | |
| IPN028149 | Hemoclip Plus Medium Ligating Clips, 25 clips/cart, Titanium | 25 | In distribution |
| IPN920951 | Hemoclip Traditional Small Ligating Clips, 25 Clips/Cart, Tantalum | 25 | In distribution |
| IPN028141 | Hemoclip Traditional Small Ligating Clips, 25 clips/cart, Titanium | 25 | In distribution |
| IPN008655 | Height 4.49 mm | 25 | In distribution |
| IPN008562 | Hemoclip Traditional Large Ligating Clips, 15 clips/cart, Tantalum | 15 | In distribution |
| IPN039592 | 6 | In distribution | |
| IPN027363 | 6 | In distribution | |
| IPN028143 | Length 12.71 mm | 15 | In distribution |
| IPN008660 | Hemoclip Traditional Medium-Large Ligating Clips, Non-Sterile 20 cart/box, Titanium | 10 | In distribution |
| IPN928367 | Depth 0.1 in | 3 | In distribution |
| IPN930252 | Depth 0.1 in | 3 | In distribution |
| IPN028168 | Length 12.38 mm | 24 | In distribution |
| IPN008928 | Hemoclip Plus Medium Ligating Clips with Tape, 10 clips/cart, Titanium | 10 | In distribution |
| IPN931025 | Horizon Medium Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN920934 | Height 4.61 mm | 25 | In distribution |
| IPN008946 | Length 3.51 mm | 25 | In distribution |
| IPN008502 | Height 4.49 mm | 25 | In distribution |
| IPN920960 | Height 7.51 mm | 10 | In distribution |
| IPN008661 | Height 10.53 mm | 15 | In distribution |
| IPN928809 | Hemolok Large Ligating Clips, Polymer | 6 | In distribution |
| IPN931021 | Height 2.87 mm | 6 | In distribution |
| IPN028165 | Height 2.87 mm | 6 | In distribution |
| IPN008583 | Height 4.49 mm | 10 | In distribution |
| IPN010798 | Length 35 cm | In distribution | |
| IPN920981 | Height 7.21 mm | 6 | In distribution |
| IPN920967 | Height 8.35 mm | 6 | In distribution |
| IPN920980 | Horizon Medium Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN915127 | Height 7.54 mm | 10 | In distribution |
| IPN915024 | Height 2.67 mm | 25 | In distribution |
| IPN028155 | Hemoclip Plus Small Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN915120 | Length 5.8 mm | 25 | In distribution |
| IPN008927 | Hemoclip Plus Small Ligating Clips, 25 clips/cart, Titanium | 25 | In distribution |
| IPN915136 | Height 2.75 mm | 25 | In distribution |
| IPN028164 | Horizon Small Ligating Clips, 4-Pack, Titanium | 24 | In distribution |
| IPN028174 | Height 1.91 mm | 6 | In distribution |
| IPN915122 | Height 2.69 mm | 25 | In distribution |
| IPN920976 | Length 8.98 mm | 24 | In distribution |
| IPN009033 | Height 9.3 mm | 6 | In distribution |
| IPN008924 | Hemoclip Plus Medium Ligating Clips with Tape, 25 clips/cart, Titanium | 25 | In distribution |
| IPN915138 | Hemoclip Plus Small Strongpoint Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN930253 | Height 13.84 mm | 6 | In distribution |
| IPN928807 | Height 8.35 mm | 6 | In distribution |
| IPN008932 | Length 9.27 mm | 10 | In distribution |
| IPN920965 | Height 10.53 mm | 10 | In distribution |
| IPN927870 | Depth 0.06 in | 3 | In distribution |
| IPN920959 | Length 3.55 mm | 25 | In distribution |
| IPN915023 | Height 2.67 mm | 25 | In distribution |
| IPN930245 | Height 9.3 mm | 6 | In distribution |
| IPN002009 | Length 8.98 mm | 6 | In distribution |
| IPN920973 | Height 2.87 mm | 24 | In distribution |
| IPN915119 | Height 4.61 mm | 25 | In distribution |
| IPN914924 | Horizon Small, Wide Ligating Clips, 4-Pack, Titanium | 6 | In distribution |
| IPN915076 | Height 7.51 mm | 10 | In distribution |
| IPN002003 | Horizon Small Ligating Clips, 4-Pack, Titanium | 24 | In distribution |
| IPN008926 | Hemoclip Plus Small Ligating Clips with Tape, 25 clips/cart, Titanium | 25 | In distribution |
| IPN915066 | Height 2.67 mm | 25 | In distribution |
| IPN915031 | Length 9.27 mm | 10 | In distribution |
| IPN915065 | Length 5.79 mm | 25 | In distribution |
| IPN008563 | Length 12.71 mm | 15 | In distribution |
| IPN914929 | Length 12.38 mm | 6 | In distribution |
| IPN915126 | Height 2.69 mm | 10 | In distribution |
| IPN930254 | Length 0.78 in | 3 | In distribution |
| IPN009039 | Hemolok Medium Ligating Clips, Polymer | 6 | In distribution |
| IPN930501 | 6 | In distribution | |
| IPN028173 | Length 12.38 mm | 6 | In distribution |
| IPN028142 | Length 9.27 mm | 10 | In distribution |
| IPN915069 | Length 9.27 mm | 10 | In distribution |
| IPN915077 | Length 12.71 mm | 10 | In distribution |
| IPN920961 | Length 12.71 mm | 15 | In distribution |
| IPN920946 | Length 3.51 mm | 25 | In distribution |
| IPN928368 | Height 13.84 mm | 6 | In distribution |
| IPN028159 | Height 10.56 mm | 10 | In distribution |
| IPN028133 | Height 2.67 mm | 25 | In distribution |
| IPN002004 | Height 2.87 mm | 6 | In distribution |
| IPN920938 | Hemoclip Plus Medium Ligating Clips with Tape, 10 clips/cart, Titanium | 10 | In distribution |
| IPN915054 | Height 2.67 mm | 10 | In distribution |
| IPN008661 | Length 12.71 mm | 15 | In distribution |
| IPN931029 | Height 10.07 mm | 6 | In distribution |
| IPN930251 | Height 9.3 mm | 6 | In distribution |
| IPN920982 | Horizon Large Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN028151 | Hemoclip Plus Small Ligating Clips, 25 clips/cart, Titanium | 25 | In distribution |
| IPN028157 | Length 9.27 mm | 10 | In distribution |
| IPN915075 | Length 3.55 mm | 10 | In distribution |
| IPN928364 | Hemolok Medium-Large Ligating Clips, Polymer | 6 | In distribution |
| IPN008668 | Hemoclip Traditional Large Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN008585 | Hemoclip Traditional Small Ligating Clips, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN931023 | Height 2.87 mm | 6 | In distribution |
| IPN919213 | 6 | In distribution | |
| IPN920935 | Length 5.8 mm | 25 | In distribution |
| IPN028130 | Height 13.84 mm | 6 | In distribution |
| IPN920939 | Hemoclip Plus Medium Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN028136 | Height 4.49 mm | 10 | In distribution |
| IPN914921 | Height 2.87 mm | 6 | In distribution |
| IPN920979 | Horizon Small, Wide Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN920978 | Height 2.87 mm | 6 | In distribution |
| IPN915007 | Height 4.49 mm | 25 | In distribution |
| IPN920974 | Height 2.87 mm | 6 | In distribution |
| IPN008925 | Height 4.61 mm | 25 | In distribution |
| IPN915051 | Length 5.79 mm | 10 | In distribution |
| IPN008587 | Length 9.27 mm | 10 | In distribution |
| IPN915006 | Height 4.49 mm | 25 | In distribution |
| IPN915137 | Hemoclip Plus Small Strongpoint Ligating Clips, with Tape, 10 clips/cart, Titanium | 10 | In distribution |
| IPN028144 | Length 5.79 mm | 10 | In distribution |
| IPN914923 | Horizon Small Ligating Clips, 4-Pack, Titanium | 24 | In distribution |
| IPN008590 | Hemoclip Traditional Medium Ligating Clips, 25 clips/cart, Stainless Steel | 25 | In distribution |
| IPN915125 | Hemoclip Plus Small Ligating Clips with Tape, 10 clips/cart, Titanium | 10 | In distribution |
| IPN008563 | Length 12.71 mm | 15 | In distribution |
| IPN028128 | Hemolok Large Ligating Clips, Polymer | 6 | In distribution |
| IPN008927 | Length 3.46 mm | 25 | In distribution |
| IPN028146 | Length 9.27 mm | 10 | In distribution |
| IPN008550 | Length 9.27 mm | 10 | In distribution |
| IPN008947 | Height 2.75 mm | 25 | In distribution |
| IPN008502 | Length 5.79 mm | 25 | In distribution |
| IPN008535 | Length 3.55 mm | 25 | In distribution |
| IPN008657 | Hemoclip Traditional Small Ligating Clips, 25 clips/cart, Titanium | 25 | In distribution |
| IPN930499 | 6 | In distribution | |
| IPN914927 | Height 7.21 mm | 6 | In distribution |
| IPN914925 | Horizon Medium Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN028150 | Length 3.46 mm | 25 | In distribution |
| IPN928663 | In distribution | ||
| IPN928365 | Width 0.3 in | 3 | In distribution |
| IPN008931 | Hemoclip Plus Small Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN010797 | Length 35 cm | In distribution | |
| IPN028167 | Length 8.98 mm | 24 | In distribution |
| IPN028172 | Height 7.21 mm | 6 | In distribution |
| IPN920936 | Length 3.46 mm | 25 | In distribution |
| IPN915042 | Hemoclip Traditional Large Ligating Clips, Non-Sterile 15 clips/cart, Tantalum | 15 | In distribution |
| IPN008669 | Height 10.53 mm | 10 | In distribution |
| IPN008666 | Hemoclip Traditional Small Ligating Clips, Non-Sterile 10 clips/cart, Titanium | 10 | In distribution |
| IPN008501 | Height 4.49 mm | 25 | In distribution |
| IPN002013 | Horizon Large Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN931027 | Length 8.98 mm | 6 | In distribution |
| IPN920948 | Height 2.75 mm | 10 | In distribution |
| IPN009042 | Height 9.3 mm | 6 | In distribution |
| IPN002006 | Length 5.89 mm | 24 | In distribution |
| IPN008548 | Length 9.27 mm | 10 | In distribution |
| IPN008660 | Height 7.51 mm | 10 | In distribution |
| IPN920944 | Length 12.6 mm | 10 | In distribution |
| IPN009034 | Hemolok Clips, NOT FOR SALE, NOT FOR HUMAN USE | 6 | In distribution |
| IPN008563 | Hemoclip Traditional Large Ligating Clips, Non-Sterile 15 clips/cart, Tantalum | 15 | In distribution |
| IPN008502 | Height 4.49 mm | 25 | In distribution |
| IPN028125 | Height 6.32 mm | 6 | In distribution |
| IPN930244 | Depth 0.06 in | 3 | In distribution |
| IPN920963 | Height 2.67 mm | 10 | In distribution |
| IPN930248 | Depth 0.15 in | 3 | In distribution |
| IPN008651 | Length 12.71 mm | 10 | In distribution |
| IPN008947 | Length 3.51 mm | 25 | In distribution |
| IPN915070 | Height 10.53 mm | 15 | In distribution |
| 544240 | 6 | In distribution | |
| IPN028163 | Hemoclip Plus Small Strongpoint Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN920968 | Width 0.3 in | 3 | In distribution |
| IPN008662 | Length 12.71 mm | 15 | In distribution |
| IPN930247 | Height 13.84 mm | 6 | In distribution |
| IPN920971 | Hemolok Xtra-LargeLigating Clips, Polymer | 6 | In distribution |
| IPN028134 | Height 7.51 mm | 10 | In distribution |
| IPN008584 | Hemoclip Traditional Medium Ligating Clips, Non-Sterile, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN915053 | Hemoclip Traditional Small Ligating Clips, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN915067 | Height 2.67 mm | 25 | In distribution |
| IPN915078 | Length 12.71 mm | 10 | In distribution |
| IPN002016 | Horizon Microclip Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN027365 | 6 | In distribution | |
| IPN920975 | Horizon Medium Ligating Clips, 4-Pack, Titanium | 24 | In distribution |
| IPN008586 | Hemoclip Traditional Small Ligating Clips, Non-Sterile, 10 clips/cart, Tantalum | 10 | In distribution |
| IPN920964 | Length 9.27 mm | 10 | In distribution |
| IPN920977 | Height 10.07 mm | 24 | In distribution |
| IPN008946 | Height 2.75 mm | 25 | In distribution |
| IPN914922 | Horizon Small, Wide Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN915130 | Hemoclip Plus Large Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN008933 | Length 9.27 mm | 10 | In distribution |
| IPN028126 | Hemolok Medium-Large Ligating Clips, Polymer | 6 | In distribution |
| IPN915184 | Height 9.3 mm | 6 | In distribution |
| IPN915129 | Length 12.6 mm | 10 | In distribution |
| IPN920970 | Width 0.55 in | 3 | In distribution |
| IPN008929 | Height 4.61 mm | 10 | In distribution |
| IPN915181 | Hemolok Medium Ligating Clips, Polymer | 6 | In distribution |
| IPN914931 | Height 1.91 mm | 6 | In distribution |
| IPN002003 | Length 3.63 mm | 24 | In distribution |
| IPN028171 | Length 5.89 mm | 6 | In distribution |
| IPN008628 | Hemoclip Traditional Medium Ligating Clips, Non-Sterile, 10 clips/cart, Stainless Steel | 10 | In distribution |
| IPN915121 | Length 3.46 mm | 25 | In distribution |
| IPN924909 | Length 35 cm | In distribution | |
| IPN002014 | Length 12.38 mm | 24 | In distribution |
| IPN008550 | Height 7.51 mm | 10 | In distribution |
| IPN039776 | Outer Diameter 10 mm | In distribution | |
| IPN920941 | Hemoclip Plus Small Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN920956 | Hemoclip Traditional Medium-Large Ligating Clips, 16 cart/box, Tantalum | 10 | In distribution |
| IPN930242 | Height 6.32 mm | 6 | In distribution |
| IPN008637 | Height 2.67 mm | 10 | In distribution |
| IPN915072 | Length 5.79 mm | 10 | In distribution |
| IPN008592 | Height 2.67 mm | 25 | In distribution |
| IPN920983 | Horizon Microclip Ligating Clips, Single Pack, Titanium | 6 | In distribution |
| IPN930246 | Depth 0.1 in | 3 | In distribution |
| IPN914926 | Height 4.68 mm | 24 | In distribution |
| IPN919211 | 3 | In distribution | |
| IPN009036 | Height 13.84 mm | 6 | In distribution |
| IPN008636 | Height 2.67 mm | 10 | In distribution |
| IPN927869 | Height 8.35 mm | 6 | In distribution |
| IPN028132 | Length 5.79 mm | 25 | In distribution |
| IPN920958 | Length 5.79 mm | 25 | In distribution |
| IPN002004 | Length 3.68 mm | 6 | In distribution |
| IPN008594 | Length 9.27 mm | 10 | In distribution |
| IPN930187 | Length 35 cm | In distribution | |
| IPN039593 | 3 | In distribution | |
| IPN028160 | Hemoclip Plus Small Strongpoint Ligating Clips, with Tape, 25 clips/cart, Titanium | 25 | In distribution |
| IPN002010 | Height 7.21 mm | 24 | In distribution |
| IPN028138 | Height 7.51 mm | 10 | In distribution |
| IPN008949 | Height 2.75 mm | 10 | In distribution |
| IPN008535 | Length 3.55 mm | 25 | In distribution |
| IPN008930 | Hemoclip Plus Small Ligating Clips with Tape, 10 clips/cart, Titanium | 10 | In distribution |
| IPN028152 | Length 5.8 mm | 10 | In distribution |
| IPN915074 | Hemoclip Traditional Small Ligating Clips, 10 clips/cart, Titanium | 10 | In distribution |
| IPN009040 | Hemolok Medium-Large Ligating Clips, Polymer | 6 | In distribution |
| IPN928369 | Length 0.78 in | 3 | In distribution |
| IPN008926 | Length 3.46 mm | 25 | In distribution |
| IPN915071 | Length 12.71 mm | 15 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Aesculap | Aesculap AG | 19 |
| Medline | Medline Industries, Inc. | 15 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| E-Pack | Ethicon, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
| Clip 9 Vitalitec | Peters Surgical | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251054 | 2025-07-03 |
| K232970 | 2024-01-12 |
| K230480 | 2023-04-28 |
| K161758 | 2016-09-07 |
| K133202 | 2013-12-03 |
| K132658 | 2013-11-27 |
| K062914 | 2006-11-02 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2023-04-28 | Class II | Under Investigation by firm | Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the affected product is missing a key feature that restricts the application of the clip to the applier. With this step feature missing on the | 146,606 units | |
| Teleflex Medical LLC | 510(k) number | 2017-10-05 | Class II | Under Investigation by firm | The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. | 13,710 units | 2023-01-20 |
| Teleflex Medical LLC | 510(k) number | 2013-08-08 | Class II | Error in labeling | The manufacturing and expiration dates are not printed on the blister pack label. | 8,220 ea. | 2016-08-15 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-04 | Class II | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, | 34491 devices | |
| 2019-10-04 | Class II | Under Investigation by firm | Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a discrepancy in the specification a component. Misloading and/or jamming may lead to clips falling out of the applier, clip breakage, | 4099 devices | |
| 2016-02-02 | Class II | Nonconforming Material/Component | The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. | 543 ea. | 2017-08-11 |
| 2014-12-03 | Class II | Labeling Change Control | The manufacturing dates and expiration dates were transposed on the Tyvek label. | 3180 units | 2017-11-24 |
| 2012-09-25 | Class II | Packaging process control | Product is being recalled due to the possibility that the tray may contain pinholes, compromising product sterility. | 126 units | 2012-11-08 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2008-08-22 | Not classified | Packaging process control | A hole in the sterile unit blister pack was detected that would compromise sterility. | 786036 (total pieces) | 2012-03-15 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 854,448 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 3,656,100 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 374,760 clips | 2007-11-14 |
| 2006-04-12 | Not classified | Other | The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephre | 5,573,400 clips | 2007-11-14 |
| 2004-01-23 | Not classified | Other | Malformation of the Hem-o-lok SMX clip. | 70 sales units | 2004-05-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.