Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arteri
Summary
The FDA issued a Class II for Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-n by B Braun Medical Inc. Reason: Potential for leakage at the catheter hub..
Details
Source
Device Recall
External ID
Z-0009-2023
Action Date
2022-10-12
Status
Ongoing
Category
device
Product Description
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Lot/Code Info: 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
Quantity Affected: 94,000 US
Reason for Recall
Potential for leakage at the catheter hub.
Distribution
Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-01
Company
Breinigsville, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (B Braun Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does B Braun Medical Inc have FDA actions?
B Braun Medical Inc has 282 FDA actions in our database, including 269 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0009-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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