Integra®
Epidural Tray, Single Shot, 17G Tuohy
1manufacturer
181catalogue numbers in this listing
33recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Integra Pain Management, United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K945484 |
| Record published | 2018-06-20 |
| Record revised | 2023-12-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C; Storage environment temperature 68 to 77 °F; Special storage condition: Do Not Use if Package is Damaged |
| Packaging | Case of 10, case of 20 |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-2532 | Withdrawn | |
| 3403959 | Withdrawn | |
| CUS002-01 | Withdrawn | |
| 3104020 | Withdrawn | |
| 3404199 | Withdrawn | |
| 3605441 | Withdrawn | |
| 10-1879-00 | Withdrawn | |
| 3403051 | Withdrawn | |
| 10-2180 | Withdrawn | |
| 3404553 | Withdrawn | |
| CUS1517 | Withdrawn | |
| 3404544 | Withdrawn | |
| 10-1222-03 | Withdrawn | |
| 3404364 | Withdrawn | |
| 3405147 | Withdrawn | |
| 3405390 | Withdrawn | |
| 3403644 | Withdrawn | |
| 3405431 | Withdrawn | |
| CUS1697-01 | Withdrawn | |
| 3405254 | Withdrawn | |
| 3404783 | Withdrawn | |
| 3404009 | Withdrawn | |
| CUS032-01 | Withdrawn | |
| CUS858 | Withdrawn | |
| 3403776 | Withdrawn | |
| 3404288 | Withdrawn | |
| 20-3462-01 | Withdrawn | |
| 3405373 | Withdrawn | |
| SS3308 | Withdrawn | |
| 3403652 | Withdrawn | |
| 3404962 | Withdrawn | |
| CUS893-01 | Withdrawn | |
| 3405128 | Withdrawn | |
| 3403906 | Withdrawn | |
| 3405059 | Withdrawn | |
| CUS1415-04 | Withdrawn | |
| CUS1569-01 | Withdrawn | |
| 3403949 | Withdrawn | |
| CUS1146-01 | Withdrawn | |
| 3405365 | Withdrawn | |
| CUS1016 | Withdrawn | |
| 3404859 | Withdrawn | |
| 3405376 | Withdrawn | |
| CUS1806 | Withdrawn | |
| CUS161 | Withdrawn | |
| CUS1668-03 | Withdrawn | |
| CUS1338-02 | Withdrawn | |
| CUS1220 | Withdrawn | |
| 3403018 | Withdrawn | |
| CUS1020 | Withdrawn | |
| SS1229 | Withdrawn | |
| CUS701-01 | Withdrawn | |
| SS3271 | Withdrawn | |
| 3404768 | Withdrawn | |
| CUS766-05 | Withdrawn | |
| 3404328 | Withdrawn | |
| SS2252 | Withdrawn | |
| 3104102 | Withdrawn | |
| 3405408 | Withdrawn | |
| CUS1021 | Withdrawn | |
| SS3247-01 | Withdrawn | |
| 3405109 | Withdrawn | |
| CUS1010 | Withdrawn | |
| 20-2340 | Withdrawn | |
| 3404797 | Withdrawn | |
| CUS293-01 | Withdrawn | |
| CUS515 | Withdrawn | |
| SS1409 | Withdrawn | |
| CUS1722-01 | Withdrawn | |
| 3405414 | Withdrawn | |
| 20-2063-01 | Withdrawn | |
| CUS700-02 | Withdrawn | |
| 3405284 | Withdrawn | |
| CUS1172-01 | Withdrawn | |
| CUS001 | Withdrawn | |
| RSM448 | Withdrawn | |
| 3405159 | Withdrawn | |
| CUS1234 | Withdrawn | |
| SS1337-01 | Withdrawn | |
| 3404249 | Withdrawn | |
| 20-1462-01 | Withdrawn | |
| 3405121 | Withdrawn | |
| 3404520 | Withdrawn | |
| CUS1750 | Withdrawn | |
| RSM394 | Withdrawn | |
| 20-1281-01 | Withdrawn | |
| 3404915 | Withdrawn | |
| 3401013 | Withdrawn | |
| CUS1161-01 | Withdrawn | |
| CUS096-02 | Withdrawn | |
| 3104019 | Withdrawn | |
| CUS408 | Withdrawn | |
| 3404937 | Withdrawn | |
| 10-2216 | Withdrawn | |
| 3404470 | Withdrawn | |
| 3404230 | Withdrawn | |
| 3405060 | Withdrawn | |
| 3405191 | Withdrawn | |
| CUS034-02 | Withdrawn | |
| CUS1019-02 | Withdrawn | |
| 3405426 | Withdrawn | |
| 3405119 | Withdrawn | |
| CUS1346-01 | Withdrawn | |
| 3404816 | Withdrawn | |
| 3402953 | Withdrawn | |
| 3405294 | Withdrawn | |
| 10-2145 | Withdrawn | |
| 3404799 | Withdrawn | |
| 20-2160 | Withdrawn | |
| 3404551 | Withdrawn | |
| 3404221 | Withdrawn | |
| 3404533 | Withdrawn | |
| 10-2533 | Withdrawn | |
| 3405132 | Withdrawn | |
| 3403927 | Withdrawn | |
| 3404552 | Withdrawn | |
| CUS025 | Withdrawn | |
| 3405452 | Withdrawn | |
| CUS1536-06 | Withdrawn | |
| 3404388 | Withdrawn | |
| 3404791 | Withdrawn | |
| CUS1221-02 | Withdrawn | |
| CUS1797 | Withdrawn | |
| RSM442 | Withdrawn | |
| 10-2815 | Withdrawn | |
| 3405288 | Withdrawn | |
| 3405009 | Withdrawn | |
| 3405325 | Withdrawn | |
| RSM395 | Withdrawn | |
| CUS1407-06 | Withdrawn | |
| CUS1664-01 | Withdrawn | |
| 20-2073-01 | Withdrawn | |
| 3404942 | Withdrawn | |
| CUS610 | Withdrawn | |
| 3404419 | Withdrawn | |
| RSM397 | Withdrawn | |
| 3403542 | Withdrawn | |
| CUS1427 | Withdrawn | |
| 20-3118-01 | Withdrawn | |
| CUS1015 | Withdrawn | |
| 3404626 | Withdrawn | |
| 3404519 | Withdrawn | |
| CUS1737-01 | Withdrawn | |
| CUS1538-07 | Withdrawn | |
| ESS14-02 | Withdrawn | |
| 10-2051 | Withdrawn | |
| 3405186 | Withdrawn | |
| 3405136 | Withdrawn | |
| CUS702 | Withdrawn | |
| 3405361 | Withdrawn | |
| 3404543 | Withdrawn | |
| CUS607 | Withdrawn | |
| RSM377 | Withdrawn | |
| 3405157 | Withdrawn | |
| 3404784 | Withdrawn | |
| CUS1400-01 | Withdrawn | |
| CUS1568-01 | Withdrawn | |
| CUS1600 | Withdrawn | |
| CUS1164-02 | Withdrawn | |
| CUS1121-01 | Withdrawn | |
| SS3114-01 | Withdrawn | |
| 3405316 | Withdrawn | |
| RSM441 | Withdrawn | |
| 3405193 | Withdrawn | |
| CUS1594-01 | Withdrawn | |
| 3405116 | Withdrawn | |
| 3405353 | Withdrawn | |
| CUS854-02 | Withdrawn | |
| 3403603 | Withdrawn | |
| CUS946-02 | Withdrawn | |
| 13-2890 | Withdrawn | |
| CUS1428 | Withdrawn | |
| 3404120 | Withdrawn | |
| 3404375 | Withdrawn | |
| 3405448 | Withdrawn | |
| 3404858 | Withdrawn | |
| 3405283 | Withdrawn | |
| CUS1537-06 | Withdrawn | |
| 20-2118-01 | Withdrawn | |
| CUS1044-02 | Withdrawn | |
| 3402986 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 1,340 |
| Arrow | Teleflex Medical LLC | 508 |
| Halyard | Avanos Medical, Inc. | 422 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| BD Luer-Lok, BD Glaspak | Becton, Dickinson AND Company | 36 |
| Contiplex® | B. Braun Medical Inc. | 34 |
| Stimulong Sono | Pajunk Gmbh Medizintechnologie | 27 |
| Clint Pharmaceuticals | ICU Medical, Inc | 26 |
Showing 12 of 109. All products under Anesthesia Conduction Kit
Recalls Naming This Product
31 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 |
|---|---|---|---|---|---|---|---|
| Integra Pain Management | 510(k) number | 2013-10-28 | Class II | Component design/selection | Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall | 359,250 | 2014-01-29 |
| Integra Pain Management | 510(k) number | 2012-06-07 | Class III | Packaging process control | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. | 4 cases x 10 units per case | 2012-08-07 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 70 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 600 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 100 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 120 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 150 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 350 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 240 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 150 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 200 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 50 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 20 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 680 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 40 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 120 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 30 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 40 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 70 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 130 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 20 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 90 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 40 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 30 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 40 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 20 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 10 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 50 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 10 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 60 units | 2009-10-23 |
| Integra Pain Management | 510(k) number | 2009-07-13 | Not classified | Packaging process control | Lack of packaging seal integrity on various pain management kits may compromise sterility of contents. | 20 units | 2009-10-23 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2016-08-24 | Class II | Employee error | Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer. | 320 packages | 2016-12-19 |
| 2016-08-04 | Class II | Other | Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays. | 200 packages (20 cases) | 2016-12-19 |
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.