Maquet Cardiovascular, LLC Recall 89119
Description: Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Maquet Cardiovascular, LLC Recall 89119 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0403-2022 |
| Event ID | 89119 |
| Event Description | Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IL and NC. |
| Quantity | 2 |
| Recall 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. |
| Device Classification | 20211229 |
| Device 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 |
| Center Classification Date | 20211220 |
| Recall Initiation Date | 20211201 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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