W L Gore recalls pediatric vascular grafts with incorrect inner diameter labeling (5mm vs 6mm) that could lead to improper medical use. Affected units include specific reference numbers and serials.
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.
W L Gore is recalling pediatric vascular grafts that may be incorrectly labeled as 5mm when they are 6mm or vice versa. This labeling error could lead to improper medical use if the grafts are not correctly sized for the patient's needs.
The grafts may be incorrectly labeled as 5mm when they are actually 6mm or vice versa. This size mismatch could lead to improper medical use if the grafts are not correctly sized for the patient's needs.
Pediatric patients receiving vascular grafts from this specific product line. Medical professionals using the recalled grafts are most at risk due to potential mislabeling.
Check for reference numbers HPT060015 or HPT060015A with specific serial numbers listed in the recall notice. The product is only available by prescription and is sterile.
Look for reference numbers HPT060015 or HPT060015A with the listed serial numbers to confirm if your graft is affected.
The recall is due to potential labeling errors that could lead to improper medical use. Affected grafts should be checked against the list provided in the recall notice.
Check for reference numbers HPT060015 or HPT060015A with the specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so contact the manufacturer directly for guidance on next steps.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-2293-2021 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-2293-2021 from W L Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
