Z-0830-2018Class II

Mallinckrodt Institute Percutaneous Gastrostomy Set

Name: Z-0830-2018 Mallinckrodt Institute Percutaneous Gastrostomy Set
Creator: Cook Inc.
Published: 2017-10-19
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-10-19 / Terminated

FDA source

Cook Inc. began a recall of Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding on 2017-10-19. FDA classified it as Class II and gives the reason as "Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0830-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-19
Posted: 2018-03-01
Terminated: 2019-04-16
Recalling firm: Cook Incorporated
Product: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
FDA 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 in commerce: 615
Distribution: US Nationwide Distribution
Product codes and lots: WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0830-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0830-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0831-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01
Z-0832-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code KNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)