Z-0832-2018 Class II Terminated
FDA device recall Z-0832-2018 was initiated by Cook Inc. on Oct 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 Apr 16, 2019). Affected quantity: Quantities co-mingled into line 1.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Oct 19, 2017
- Termination Date
- Apr 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Quantities co-mingled into line 1
Product Description
Wills-Oglesby 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-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0832-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026