Z-0785-2016 Class II Terminated
FDA device recall Z-0785-2016 was initiated by Bard Peripheral Vascular Inc on Jan 5, 2016 and is designated Class II. Reason for recall: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft. The recall status is terminated (terminated Mar 25, 2016). Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 17, 2016
- Initiation Date
- Jan 5, 2016
- Termination Date
- Mar 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Reason for Recall
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Distribution Pattern
Distributed in the states of AL, TX, and CA.
Code Information
Product Code: DF6006SC Lot Number: VTZE1782
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0785-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026