Z-0831-2018 Class II Terminated
FDA device recall Z-0831-2018 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: Quantities co-mingled into line 1.
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
- Quantities co-mingled into line 1
Product Description
Percutaneous Gastrojejunostomy 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-1200-WH- 050493 Lot number: NS7587941