Z-0830-2018 Class II Terminated
FDA device recall Z-0830-2018 was initiated by Cook Inc. on October 19, 2017 and is designated Class II. Reason for recall: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. The recall status is terminated (terminated April 16, 2019). Affected quantity: 615.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- October 19, 2017
- Termination Date
- April 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 615
Product Description
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason for Recall
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Distribution Pattern
US Nationwide Distribution
Code Information
WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495