B. Braun Medical, Inc.: B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.; B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits conta

Agency Publication Date: February 9, 2018

Affected Products

Product: Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.

Product: Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061523813. 0061536453.

Product: Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061483775. 0061486469. 0061519983. 0061525310. 0061529050. 0061531352. 0061535252. 0061540004.

Product: Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061481027. 0061517645. 0061523759. 0061525288. 0061532533. 0061537872. 0061482545. 0061520138. 0061525101. 0061530202. 0061536397. 0061541286. 0061546528. 0061522617.

Product: Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061482582. 0061509281. 0061523764. 0061539142. 0061541519. 0061545624. 0061549251. 0061523766. 0061536442. 0061549079. 0061525251. 0061536434. 0061534703. 0061480989. 0061486228. 0061519902. 0061523684. 0061530885. 0061536042. 0061539966. 0061546081. 0061550336.

Product: PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061525340. 0061535836.

Product: Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061480990. 0061519897. 0061522568. 0061528966. 0061531310. 0061536405. 0061543200.

Product: Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061480957.

Product: Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061522622. 0061537909.

Product: Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

0061539146. 0061540984.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78878

Status: Resolved

Manufacturer: B. Braun Medical, Inc.

Manufactured In: United States

Units Affected: 10 products (8630 units; 700; 11,920 units; 2480 units; 6720 units; 700 units; 2660 units; 120 units; 460 units; 300 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.