Z-0729-2022 Class II Terminated
FDA device recall Z-0729-2022 was initiated by Maquet Cardiovascular, LLC on Jan 14, 2022 and is designated Class II. Reason for recall: Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD… The recall status is terminated (terminated Sep 19, 2023). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2022
- Initiation Date
- Jan 14, 2022
- Termination Date
- Sep 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Reason for Recall
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Distribution Pattern
US Nationwide distribution in the state of MO.
Code Information
Lot Number: 21B10 S/N: 1318567653 UDI: (01)00384401017608(11)210210(17)260131(21)1318567653GS(10)21B10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0729-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026