Device product
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Z-0830-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 615
- Official record key
device-enforcement:Z-0830-2018
Official wording
Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Code information: WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.