FDA Medical Device Recalls (openFDA)
Cook Inc.: Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
- Recall number
- Z-0832-2018
- Recalling firm
- Cook Inc.
- Product
- Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
- Status
- Terminated
- Initiated
- 2017-10-19
- Posted
- not on file
- Terminated
- 2019-04-16
- Reason
- Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
- Root cause
- Under Investigation by firm
- Action
- On October 19, 2017 an URGENT MEDICAL DEVICE RECALL letter was mailed to customers requesting that they examine inventory for affected product, immediately quarantine and return product to recalling firm for credit. Questions or concerns can be directed to 1-800-457-4500 or 812-330-2235.
- Quantity
- Quantities co-mingled into line 1
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- WOGS-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28