Reported Aug 25, 2021 · Ongoing
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the…
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. · 3750 W Kiltie Ln · Flagstaff, AZ · 86005-8712
Is this the product you have?
- Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO
- for the following Reference numbersHPT060015
- UDI(01)00733132606368
- HPT060015A UDI(01)00733132606375
- Lot codes and dates
- Serial Number for HPT060015A6185496PP001
- and Serial Numbers for HPT060015
6185502PP0016185502PP0026185502PP0036185502PP0046185502PP0066185502PP0076185502PP0096185502PP0106185503PP0016185503PP0026185503PP0046185503PP0056185503PP0066185503PP0076185503PP0086185503PP0096185503PP010
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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