B. Braun Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0569-2018)

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:

Pencan Spinal Needle Tray. Product Catalog Number: 333865. 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-0569-2018

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: 11,920 units

Code Information:

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

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated