Reported Oct 5, 2022 · Ongoing
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
G11949 | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 |
G09201 | C-HDOC-18-40-0-2 |
G26925 | C-THDOC-18-40-0-2-HTS |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00827002092013Lots/Expiration Dates: 14797780 16-06-2027 C-HDOC-18-40-0-2 G09201 UDI-DI: 00827002092013 2 00827002269255Lots/Expiration Dates: NS14807603 22-06-2027 C-THDOC-18-40-0-2-HTS G26925 UDI-DI: 00827002269255 3 Lots/Expiration Dates: NS14818388 29-06-2027 - Amount recalled
- 25 US
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.
Want the full recall guide?
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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