Recalls / —

—#201291

Product

Perifix / Epidural anesthesia kit (10 count carton)

FDA product code

OGE — Epidural Anesthesia Kit

Device class

Class 2

Medical specialty

Anesthesiology

Affected lot / code info

Model No. 332217, 332097, 332220, 332078; GTIN: 04046964178283, 04046964177361, 04046964177361, 04046964178320, 04046964177200; Lot No. 0061850767, 0061855339, 00618553400061858554, 0061837264.

Why it was recalled

Kits were assembled with the incorrect Filter Straw.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Customers received a recall notification dated 06/05/2023 by mail notifying them that affected lots of Epidural Kits were inadvertently assembled with the incorrect Filter Straw. The recall notification asks customers to determine if any affected devices are in inventory and subsequently quarantine any identified product, return the Product Recall Acknowledgement Form notating any affected devices currently in quarantine, and return the form by fax to 610-849-1197 or by email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. Coordination of product return for provision of credit/replacement will commence upon return of the form. If product has been further distributed the firm asks that the recall notification be forwarded to those consignees down to the consumer level. Customers with any questions can direct them to BBMI's Postmarket Surveillance Department at 1-883-425-1464.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2023-06-05

Posted by FDA

2023-06-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #201291. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.