Halyard
ON-Q* Expansion Kits, SOAKER* Catheter, NRFit™ Connector, 2.5 in (6.5 cm), Needle 3.25 in. x 17 GA
1manufacturer
34catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051401 |
| Record published | 2016-08-10 |
| Record revised | 2023-07-31 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13535 | In distribution | |
| 13453 | In distribution | |
| 13533 | In distribution | |
| 30788 | In distribution | |
| 13458 | In distribution | |
| 13461 | In distribution | |
| 13455 | In distribution | |
| 47358 | In distribution | |
| 44948 | In distribution | |
| 44926 | In distribution | |
| 13537 | In distribution | |
| 13536 | In distribution | |
| 13539 | In distribution | |
| 13457 | In distribution | |
| 44942 | In distribution | |
| 45162 | In distribution | |
| 13534 | In distribution | |
| 45161 | In distribution | |
| 13456 | In distribution | |
| 44941 | In distribution | |
| 44947 | In distribution | |
| 13542 | In distribution | |
| 44929 | In distribution | |
| 44928 | In distribution | |
| 13454 | In distribution | |
| 13538 | In distribution | |
| 13541 | In distribution | |
| 13460 | In distribution | |
| 44950 | In distribution | |
| 45168 | In distribution | |
| 45169 | In distribution | |
| 13532 | In distribution | |
| 13465 | In distribution | |
| 44927 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| Spinaut-E | Imedicom Co., Ltd. | 9 |
| E-Cath® NRFit Tsui® | Pajunk Gmbh Medizintechnologie | 6 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
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 |
|---|---|---|---|---|---|
| 2012-06-01 | Class II | Use error | I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned. | 75 units | 2013-06-25 |
| 2012-06-01 | Class II | Use error | I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned. | 450 units | 2013-06-25 |
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.