Maquet Cardiovascular, LLC: Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

Is my product affected?

Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

• UPC 00384401017752

Check against the official notice below — it lists the full affected range.

What happened

Maquet Cardiovascular is recalling two units of Hemashield Gold Knitted Bifurcated vascular grafts (18 mm x 9 mm, reference number M002020851890) due to probable mislabeling. The affected units have serial numbers 1260004700 and 1259882880 and lot number 20C04. Instead of the labeled Hemashield Gold Knitted product, a Hemashield Platinum Woven Double Velour Bifurcated Vascular Graft (24 mm x 12 mm, serial number 1259735369) is likely packaged in the carton.

The recalled products were distributed nationwide in Illinois and North Carolina. The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of IL and NC. Quantity: 2 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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