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Recall Observatory FDA recall evidence

Device product

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

Z-0403-2022

December 01, 2021

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 89119
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0403-2022

Official wording

Reason: 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.

Code information: 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

Distribution pattern: US Nationwide distribution in the states of IL and NC.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeling