Hemashield Gold Knitted Bifurcated recall: Labeling Error
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Why was Hemashield Gold Knitted Bifurcated recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: 20C04; Serial Numbers: 1260004700 and 1259882880; UDI Code: (01)00384401017752(11)200304(17)250228(21)1260004700GS(10)20C04 (01)00384401017752(11)200304(17)250228(21)1259882880GS(10)20C04
- Product
- Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of IL and NC.
- Recall date
- December 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)