Reported Aug 31, 2016 · Terminated
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
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 Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
- Lot codes and dates
- All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480HNBR5.0-38-100-P-NS-SHETTY-050181
169 of 169 codes
G12570HNBR5.0-35-100-P-NS-DAVG08699HNBR5.0-35-100-P-NS-FC3G11204HNBR5.0-35-100-P-NS-H1G08421HNBR5.0-35-100-P-NS-H3G08918HNBR5.0-35-100-P-NS-HN1G09741HNBR5.0-35-100-P-NS-HN4G08917HNBR5.0-35-100-P-NS-HNK1G27811HNBR5.0-35-100-P-NS-JB1G08472HNBR5.0-35-100-P-NS-JB2G08809HNBR5.0-35-100-P-NS-JB3G08577HNBR5.0-35-100-P-NS-MANG08511HNBR5.0-35-100-P-NS-MIKG11652HNBR5.0-35-100-P-NS-MPAG11468HNBR5.0-35-100-P-NS-SIM1G08471HNBR5.0-35-100-P-NS-SIM2G08422HNBR5.0-35-100-P-NS-SIM3G08597HNBR5.0-35-100-P-NS-VERTG11483HNBR5.0-35-100-P-NS-WAIKATOG13803HNBR5.0-35-100-P-NS-WNBGG08805HNBR5.0-35-125-P-NS-C2G12899HNBR5.0-35-125-P-NS-C-PSG31970HNBR5.0-35-125-P-NS-DAVG11375HNBR5.0-35-125-P-NS-H1G13258HNBR5.0-35-125-P-NS-SIM2G11658HNBR5.0-35-125-P-NS-VANSCHIE1G35733HNBR5.0-35-125-P-NS-VANSCHIE2G35734HNBR5.0-35-125-P-NS-VANSCHIE3G35735HNBR5.0-35-125-P-NS-VANSCHIE4G35736HNBR5.0-35-125-P-NS-VANSCHIE5G35737HNBR5.0-35-125-P-NS-VS1
169 of 169 codes
G11475HNBR5.0-38-100-P-NS-SIM1G08584HNBR5.0-38-100-P-NS-SIM2G08420HNBR5.0-38-100-P-NS-SIM3G08585HNBR5.0-38-100-P-NS-TEGTG11193HNBR5.0-38-100-P-NS-VERTG11484HNBR5.0-38-100-P-NS-VS2G11487HNBR5.0-38-100-P-NS-VS3G11488HNBR5.0-38-100-P-NS-VTKG27829HNBR5.0-38-100-P-NS-WNBGG08582HNBR5.0-38-110-P-NS-VERTG12128HNBR5.0-38-120-P-NS-DAVG27830HNBR5.0-38-125-P-NS-H1G11378HNBR5.0-38-125-P-NS-HN2G11523HNBR5.0-38-125-P-NS-HN5G13119HNBR5.0-38-125-P-NS-JB1G11726HNBR5.0-38-125-P-NS-JB2G11883HNBR5.0-38-125-P-NS-MPAG12154HNBR5.0-38-125-P-NS-SIM1G12072HNBR5.0-38-125-P-NS-SIM2G11517HNBR5.0-38-125-P-NS-VERTG12170HNBR5.0-38-125-P-NS-VTKG11642HNBR5.0-38-40-P-NS-0G24825HNBR5.0-38-40-P-NS-KMPG09548HNBR5.0-38-65-P-NS-C1G08446HNBR5.0-38-65-P-NS-C2G08447HNBR5.0-38-65-P-NS-C3G08448HNBR5.0-38-65-P-NS-DAVG11435HNBR5.0-38-65-P-NS-FINCK-101979G11437HNBR5.0-38-65-P-NS-H1G11395HNBR5.0-38-65-P-NS-JB1
- All Lots. Catalog prefixes HNBR5.0 and HNBR6.0 Catalog/product number; Global/order number HNBR5.0-35-100-P-NS-0 G09916 HNBR5.0-35-100-P-NS-C1 G08623 HNBR5.0-35-100-P-NS-C2 G08796 HNBR5.0-35-100-P-NS-CANADA-041480
- Amount recalled
- 2,662,505
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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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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