Reported May 13, 2026 · Ongoing
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are…
Cook Incorporated
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon
- non-braided or braided with 11 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience
- Lot codes and dates
- UDI-DI 00827002119161 Lots
500 of 500 codes
1690539016905390X16888263NS168882641690539116905391X169095771691813716924645169246461692831116928311X1692831216928313169473531689965616899655168949761687929916890985169032011688585916890986168909821688826816904428168996581690320216903203169032041690538916888267168909831688826916890981168792961686434616879301168882611686434416864351168467741686914416879300168643501686914316869143XNS1686172116879297168617351686434716864347X1688266616899657168909841689965916888266168617291685714516858460
- UDI-DI 00827002119161 Lots
- Amount recalled
- 11,253
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Using this product could cause serious injury, illness or death — stop using it now.
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