Reported May 20, 2020 · Terminated
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L.…
W. L. Gore & Associates 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: W. L. Gore & Associates Inc. · 32360 N North Valley Pkwy · Phoenix, AZ · 85085-4228
Is this the product you have?
- Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
- Lot codes and dates
141 of 141 codes
Serial numbers 210772982107736421077365210773662107763121077350210773512107741421060888210773392107734021077341210774172107741821061626210772862107733621077337210772112107730421077305210773072107730821077309210776402107755921077563210775642107718321077346210773472107761621077617210776182107761921077419210775962107734521077620210776352107732221077602210773622107762221077623210776242107762521077626210776272107762821077348210773492107763321077644210773632107735221077634210776212107731821077319
- Amount recalled
- 141 devices
Why it was recalled
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
This product could cause temporary or reversible health problems — stop using it.
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