FDA Medical Device Recalls (openFDA)
Cook Inc.: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
- Recall number
- Z-0830-2018
- Recalling firm
- Cook Inc.
- Product
- Mallinckrodt Institute 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
- 615
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495
- 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