Device product
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Z-0832-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79192
- Status
- Terminated
- Classification
- Class II
- Quantity
- Quantities co-mingled into line 1
- Official record key
device-enforcement:Z-0832-2018
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-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023
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.