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Perifix recallZ-2002-2023 · B. Braun Medical, Inc. · initiated Jun 5, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Kits were assembled with the incorrect Filter Straw.

FDA root cause category: Mixed-up of materials/components

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-2002-2023
Status
Open, Classified
Initiated by the company
Jun 5, 2023
Posted by the FDA
Jun 23, 2023
Recalling firm
B. Braun Medical, Inc.
Quantity
16,070 units
Product code
OGE
Distribution
US Nationwide distribution.

Product description

Perifix / Epidural anesthesia kit (10 count carton)

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92523).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page