Reported May 21, 2014 · Terminated
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001…
Greatbatch Medical
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: Greatbatch Medical · 2300 Berkshire Ln N · Minneapolis, MN · 55441-4575
Is this the product you have?
- Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit Coax 10 Pack 5FR Bard 10636-009 8004022 Kit Coax 10 Pack 5FR Bard 10636-010 8005022 Kit Coax 10 Pack 5FR Bard The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.
- Lot codes and dates
123 of 123 codes
W1190519W1190532W1190532W1190514W1190517W1190517W1190516W1266849W1266851W1266850W1266848W1298418W1300005W1298419W1298425W1298426W1362771W1362772W1362773W1362775W1383678W1362774W1420240W1420241W1420242W1434887W1434888W1464513W1464514W1464516W1464511W1464512W1464515W1466090W1466092W1466093W1466091W1467421W1477933W1467420W1477935W1477932W1477934W1490379W1477937W1490378W1490380W1490377W1477936W1509174W1509175W1532502W1532501W1509173W1599234W1629461W1661254W1688745W1720426W1746962
- Amount recalled
- 6,642 sets (66,420 devices)
Where it was sold
- Nationwide
- UT
Why it was recalled
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
This product could cause temporary or reversible health problems — stop using it.
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