Reported Oct 5, 2022 · Ongoing
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire
- Reference Part NumberTSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
- Lot codes and dates
- TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates(GPN G01095) UDI-DI 00827002010956
1481368727-06-20271483130207-07-20271483130307-07-20271483130407-07-20271483130507-07-20271483130707-07-20271483130807-07-20271483130907-07-20271483131007-07-20271483131107-07-20271483131307-07-20271484239414-07-20271484239514-07-20271484239614-07-20271484239714-07-20271484239814-07-20271484239914-07-20271484240014-07-20271484240114-07-2027TSFB-35-200
- Lot/Expiration Date14816668 28-06-2027
- TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates
- Amount recalled
- 5571 US, 409 OUS
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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