Perifix®
PERIFIX® 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Slip LOR Tray (Kit) - Safety Engineered Tray
1manufacturer
118catalogue numbers in this listing
17recalls 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 | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | OGE |
| Device type | Epidural Anesthesia Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2021-02-17 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 20 to 25 °C; Handling environment temperature 1 to 40 °C |
| Distribution end date | 2026-06-06 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 332096 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332093 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332079 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332259 | Gauge epidural needle : 20 | 10 | In distribution |
| 339188 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332220 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332250 | Gauge epidural needle : 18 | 10 | In distribution |
| 332247 | Gauge epidural needle : 18 | 10 | In distribution |
| 333512 | Gauge (Catheter) : 19 | 25 | In distribution |
| 332254 | Gauge epidural needle : 20 | 10 | In distribution |
| 339183 | Gauge epidural needle : 17 | 10 | In distribution |
| 332612 | Gauge epidural needle : 20 | 10 | In distribution |
| 333541 | Gauge (Catheter) : 20 | 25 | In distribution |
| 332610 | Gauge epidural needle : 17 | 10 | In distribution |
| 332215 | Gauge epidural needle : 18 | 10 | In distribution |
| 332095 | Gauge (Catheter) : 19 | 10 | In distribution |
| 333514 | Gauge (Catheter) : 19 | 25 | In distribution |
| 332236 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332097 | Gauge epidural needle : 17 | 10 | In distribution |
| 332294 | Gauge (Catheter) : 20 | 12 | In distribution |
| 332234 | Gauge (Catheter) : 19 | 12 | In distribution |
| 339121 | Gauge (Catheter) : 20 | 25 | In distribution |
| 332080 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332081 | Gauge epidural needle : 18 | 10 | In distribution |
| 332200 | Gauge epidural needle : 18 | 12 | In distribution |
| 552047 | Gauge epidural needle : 17 | 10 | In distribution |
| 332098 | Gauge epidural needle : 17 | 10 | In distribution |
| 332282 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332248 | Gauge epidural needle : 17 | 10 | In distribution |
| 339120 | Gauge (Catheter) : 19 | 25 | In distribution |
| 339185 | Gauge epidural needle : 17 | 10 | In distribution |
| 332258 | Gauge epidural needle : 20 | 10 | In distribution |
| 332255 | Gauge epidural needle : 22 | 10 | In distribution |
| 332078 | Gauge epidural needle : 17 | 10 | In distribution |
| 332086 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332221 | Gauge epidural needle : 17 | 10 | In distribution |
| 333501 | Gauge (Catheter) : 19 | 25 | In distribution |
| 333532 | Gauge (Catheter) : 20 | 25 | In distribution |
| 339190 | Gauge epidural needle : 18 | 10 | In distribution |
| 339186 | Gauge epidural needle : 17 | 10 | In distribution |
| 332079 | Gauge epidural needle : 17 | 10 | In distribution |
| 332230 | Gauge epidural needle : 18 | 10 | In distribution |
| 332600 | Gauge epidural needle : 18 | 10 | In distribution |
| 339194 | Gauge (Catheter) : 20 | 12 | In distribution |
| 339189 | Gauge epidural needle : 18 | 10 | In distribution |
| 333539 | Gauge (Catheter) : 20 | 25 | In distribution |
| 332077 | Gauge epidural needle : 17 | 10 | In distribution |
| 332075 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332252 | Gauge epidural needle : 18 | 10 | In distribution |
| 339184 | Gauge epidural needle : 17 | 10 | In distribution |
| 332097 | Gauge epidural needle : 17 | 10 | In distribution |
| 333540 | Gauge (Catheter) : 20 | 25 | In distribution |
| 332290 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332212 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332609 | Gauge epidural needle : 18 | 10 | In distribution |
| 333511 | Gauge (Catheter) : 19 | 25 | In distribution |
| 332201 | Gauge (Catheter) : 20 | 12 | In distribution |
| 332078 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332217 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332256 | Gauge epidural needle : 18 | 10 | In distribution |
| 332231 | Gauge epidural needle : 18 | 10 | In distribution |
| 332604 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332211 | Gauge (Catheter) : 20 | 10 | In distribution |
| 333520 | Gauge (Catheter) : 20 | 25 | In distribution |
| 332219 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332084 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332224 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332206 | Gauge epidural needle : 18 | 10 | In distribution |
| 332238 | Gauge epidural needle : 17 | 12 | In distribution |
| 332210 | Gauge (Catheter) : 20 | 12 | In distribution |
| 332293 | Gauge (Catheter) : 24 | 12 | In distribution |
| 332223 | Gauge (Catheter) : 20 | 10 | In distribution |
| 339193 | Gauge epidural needle : 20 | 10 | In distribution |
| 332202 | Gauge (Catheter) : 20 | 12 | In distribution |
| 332251 | Gauge epidural needle : 18 | 10 | In distribution |
| 332242 | Gauge (Catheter) : 19 | 10 | In distribution |
| 339187 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332216 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332291 | Gauge (Catheter) : 20 | 12 | In distribution |
| 332222 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332209 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332082 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332239 | Gauge epidural needle : 18 | 10 | In distribution |
| 332235 | Gauge (Catheter) : 20 | 10 | In distribution |
| 339191 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332233 | Gauge epidural needle : 17 | 10 | In distribution |
| 339192 | Gauge epidural needle : 18 | 10 | In distribution |
| 333538 | Gauge (Catheter) : 24 | 25 | In distribution |
| 332098 | Gauge epidural needle : 17 | 10 | In distribution |
| 332292 | Gauge epidural needle : 20 | 10 | In distribution |
| 332249 | Gauge epidural needle : 18 | 10 | In distribution |
| 332086 | Gauge epidural needle : 17 | 10 | In distribution |
| 333521 | Gauge (Catheter) : 20 | 25 | In distribution |
| 552047 | Gauge (Catheter) : 19 | 10 | In distribution |
| 332266 | Gauge (Catheter) : 20 | 10 | In distribution |
| 332326 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 332322 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332325 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332327 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 332329 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 332330 | 10 | Withdrawn | |
| 332606 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 332338 | Gauge epidural needle : 22 | 10 | Withdrawn |
| 332321 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 332264 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 332615 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 332324 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332323 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332232 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332328 | Gauge epidural needle : 20 | 10 | Withdrawn |
| 332605 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332602 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 332229 | Gauge (Catheter) : 20 | 10 | Withdrawn |
| 332204 | Gauge (Catheter) : 19 | 12 | Withdrawn |
| 332320 | Gauge epidural needle : 17 | 10 | Withdrawn |
| 332603 | Gauge epidural needle : 18 | 10 | Withdrawn |
| 332262 | Gauge (Catheter) : 19 | 10 | Withdrawn |
| 332087 | Gauge (Catheter) : 19 | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 1,319 |
| Medline Industries, Inc. | Medline Industries, Inc. | 504 |
| Design Options® | B. Braun Medical Inc. | 361 |
| Aligned Medical Solutions | Aligned Medical Solutions | 77 |
| Arrow | Teleflex Medical LLC | 15 |
| Epidural Anesthesia Kit Clint Pharmaceuticals | CHS USA Incorporated | 11 |
| Epidural Anesthesia Kit | Pajunk Medical Systems, LP | 11 |
| Epidural Anesthesia Kit | Custom Interventional Pain Management | 10 |
| ACS | American Contract Systems, Inc. | 8 |
| Stradis Healthcare | Stradis Healthcare | 5 |
| Medline | Medline Industries, Inc. | 4 |
| Epidural Anesthesia Kit | CHS USA Incorporated | 4 |
Showing 12 of 18. All products under Epidural Anesthesia Kit
Recalls Naming This Product
17 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 48,110 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 21,270 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,760 units | |
| B. Braun Medical Inc. | UDI-DI | 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units | |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-01-22 | Class II | Process control | Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit. | 3,480 units | |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2024-01-22 | Class II | Process control | Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit. | 3,890 units | |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2023-07-31 | Class II | Process control | Product may be mislabeled with an incorrect lid stock label. | 3440 units | |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2023-06-05 | Class II | Mixed-up of materials/components | Kits were assembled with the incorrect Filter Straw. | 16,070 units | |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 540 units | 2020-08-21 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 960 units | 2020-08-21 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 200 units | 2020-08-21 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 3820 units | 2020-08-21 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 200 units | 2020-08-21 |
| B. Braun US Device Manufacturing LLC | UDI-DI | 2019-07-10 | Class II | Under Investigation by firm | The filter capacity is not achieved due to damage of the filter membrane. | 1230 units | 2020-08-21 |
Recalls
10 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 |
|---|---|---|---|---|
| 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 690 |
| 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 280 |
| 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 690 |
| 2026-01-29 | Class II | Process control | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the p | 680 |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,450 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 10,130 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 0 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 2,840 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 60 units |
| 2025-09-18 | Class II | Process control | Potential for the lid of the catheter connector to be in the incorrect position. | 5,770 units |
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.