FDA Device Recall Z-0009-2023: B Braun Medical Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0009-2023.

Recall Res Number

Z-0009-2023

Recalling Firm / Manufacturer

B Braun Medical Inc

FEI Number

3003218564

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2022-09-01

Date Posted

2022-10-06

Date Terminated

N/A

Product Code

FOZ

Event Number

90830

Product Quantity

94,000 US

Product Description Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

Reason for Recall Potential for leakage at the catheter hub.

Action Details On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs.

Distribution Pattern Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada

Code Information / Serial Numbers UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027

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Medical Device Recall: Z-0009-2023

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer