Recall Z-0403-2022— Maquet Cardiovascular, LLC
Class II · Terminated
Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2021-12-01, terminated 2024-02-28. It names one FDA 510(k) clearance: K954848. Product: Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890. 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..
- Recalling firm
- Maquet Cardiovascular, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-01
- Terminated
- 2024-02-28
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.