Reported Aug 25, 2021 · Ongoing
Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 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 5 mm, Length 10 cm, Rx Only, Sterile EO
- for the following Reference numbersHPT050010
- UDI(01)00733132606320
- HPT050010A UDI(01)00733132606337
- Lot codes and dates
- Serial Numbers for HPT050010A
6185494PP0016185494PP0026185494PP0046185494PP0066185494PP0086185494PP0096185494PP0106185494PP0116185494PP0126185495PP0016185495PP0026185495PP0046185495PP0056185495PP0066185495PP0076185495PP0096185495PP0106185495PP0116185495PP0126185495PP014
- and Serial Numbers for HPT050010
6185497PP0016185497PP0056185497PP0066185497PP0076185497PP0086185497PP0096185497PP0106185497PP0116185497PP012
- Serial Numbers for HPT050010A
- 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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