Reported Aug 31, 2016 · Terminated
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use…
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 Royal Flush Plus High-Flow 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 HNR5.0 Catalog/product number; Global/order numberHNR5.0-35-70-P-10S-PIG-RICKETTS-081983
HNR5.0-35-100-P-10S-0G09697HNR5.0-35-100-P-10S-CFPG11264HNR5.0-35-100-P-10S-PIGG09059HNR5.0-35-100-P-8S-VCFG31403HNR5.0-35-100-P-NS-0G10313HNR5.0-35-100-ST-10S-0G09565HNR5.0-35-100-ST-10S-PIGG09525HNR5.0-35-110-P-10S-0G11241HNR5.0-35-110-P-10S-PIGG11265HNR5.0-35-65-P-8S-VCFG12129HNR5.0-35-70-P-10S-0G09411HNR5.0-35-70-P-10S-CFPG11262HNR5.0-35-70-P-10S-PIGG08832
HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983G11280HNR5.0-35-70-P-4S-PEDG11281HNR5.0-35-70-P-NS-0G11959HNR5.0-35-70-ST-10S-0G09564HNR5.0-35-70-ST-10S-PIGG09050
G11282HNR5.0-35-90-P-6S-PEDG11729HNR5.0-35-90-P-8S-VCFG12799HNR5.0-35-90-ST-10S-0G11641HNR5.0-35-90-ST-10S-PIGG09197HNR5.0-38-100-P-10S-0G11267HNR5.0-38-100-P-10S-CFPG11268HNR5.0-38-100-P-10S-PIGG09285HNR5.0-38-100-P-NS-0G27874HNR5.0-38-110-P-10S-0G09461HNR5.0-38-110-P-10S-PIGG11269HNR5.0-38-70-P-10S-0G11270HNR5.0-38-70-P-10S-CFPG11271HNR5.0-38-70-P-10S-PIGG11272HNR5.0-38-70-P-NS-0G11289HNR5.0-38-80-P-10S-OPCG27877HNR5.0-38-90-P-10S-0G11273HNR5.0-38-90-P-10S-CFPG11274HNR5.0-38-90-P-10S-PIGG11275
- All Lots. Catalog prefixes HNR5.0 Catalog/product number; Global/order number
- Amount recalled
- 532,395
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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