FDA Enforcement
Class II
Ongoing
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Recall: Z-0582-2020
·
Reported December 4, 2019
Enforcement
- Recall Number
- Z-0582-2020
- Event ID
- 84169
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2019
- Initiation Date
- February 14, 2019
- Classification Date
- November 27, 2019
- Address
- 1625 W 3rd St Bldg 1, Tempe, AZ, 85281-2438, United States
Description
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason
Complaints received that products packaged with the incorrect introducer sheath size.
Code Info
Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407
Distribution
US - Nationwide OUS - None
Quantity
900 units