Device product
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Z-0582-2020
Product summary
- Event
- Event 84169
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900 units
- Official record key
device-enforcement:Z-0582-2020
Official wording
Reason: Complaints received that products packaged with the incorrect introducer sheath size.
Code information: Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407
Distribution pattern: US - Nationwide OUS - None
Derived failure modes
-
Unknown
Complaints received that products packaged with the incorrect introducer sheath size.