Reported Aug 31, 2016 · Terminated
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter…
Cook Inc.
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 Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
- Lot codes and dates
- All Lots. Catalog prefixes NR5.0 Catalog/product number
- Global/order number Centimeter Sizing
NR5.0-35-70-P-10S-VCF-CSC-20G31220NR5.0-35-70-P-10S-PIG-CSC-20G31215NR5.0-35-70-P-10S-0-CSC-20G31213NR5.0-35-100-P-10S-VCF-CSC-20G31221NR5.0-35-100-P-10S-PIG-CSC-20G31216NR5.0-35-100-P-10S-0-CSC-20
- G31214 White Vessel Sizing
NR5.0-35-70-P-10S-PIG-WSCG31224NR5.0-35-70-P-10S-CFP-WSCG31227NR5.0-35-70-P-10S-0-WSCG31228NR5.0-35-65-P-6S-VCF-WSCG31229NR5.0-35-100-P-10S-PIG-WSC
- G31226 Vessel Sizing
NR5.0-35-90-P-10S-VCF-CAVAG31233NR5.0-35-90-P-10S-PIG-CAVAG31231NR5.0-35-70-P-10S-VCF-CAVAG31232NR5.0-35-70-P-10S-PIG-CAVAG31230
- Amount recalled
- 332,255
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
This product could cause temporary or reversible health problems — stop using it.
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