Z-0582-2020 Class II Ongoing
FDA device recall Z-0582-2020 was initiated by Bard Peripheral Vascular Inc on February 14, 2019 and is designated Class II. Reason for recall: Complaints received that products packaged with the incorrect introducer sheath size. The recall status is ongoing. Affected quantity: 900 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- February 14, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 units
Product Description
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason for Recall
Complaints received that products packaged with the incorrect introducer sheath size.
Distribution Pattern
US - Nationwide OUS - None
Code Information
Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407