B. Braun Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0571-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 21, 2017

Date Posted: February 21, 2018

Recall Number: Z-0571-2018

Event ID: 78878

Reason for Recall:

B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the 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.

Status: Terminated

Product Quantity: 6720 units

Code Information:

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

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated