Maquet recalls Hemashield Gold Knitted Bifurcated Vascular Grafts (18mm x 9mm) due to probable mislabeling with Platinum models. Affected units may contain incorrect product specifications.
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
Maquet is recalling Hemashield Gold Knitted Bifurcated Vascular Grafts (18 mm x 9 mm) because they may be mislabeled with Platinum models instead of the Gold models. This could lead to incorrect medical use if the wrong graft is used during surgery.
The recall involves a probable mislabeling issue where Platinum Woven Double Velour Bifurcated Vascular Grafts (24 mm x 12 mm) may be packaged inside the carton instead of the Gold Knitted Microvel Double Velour Bifurcated Vascular Grafts (18 mm x 9 mm). Using the wrong size graft during surgery could lead to complications.
Patients undergoing vascular surgery who use these grafts are most at risk. Healthcare providers who have the recalled grafts in their inventory may also be affected.
Check for the product name 'Hemashield Gold Knitted Bifurcated Vascular Graft' with size 18 mm x 9 mm. Look for reference number M002020851890 and serial numbers 1260004700 or 1259882880.
Verify the product name, size (18 mm x 9 mm), reference number M002020851890, and serial numbers 1260004700 or 1259882880.
Hemashield Gold Knitted Bifurcated Vascular Grafts (18 mm x 9 mm) with reference number M002020851890 and serial numbers 1260004700 or 1259882880.
There is a probable mislabeling issue where Platinum Woven Double Velour Bifurcated Vascular Grafts (24 mm x 12 mm) may be packaged inside the carton instead of the Gold Knitted Microvel Double Velour Bifurcated Vascular Grafts (18 mm x 9 mm).
The recall does not specify a remedy, so check the product details to confirm if it is affected and contact the manufacturer for further guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0403-2022 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0403-2022 from Maquet. 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.
