CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Mallinckrodt Institute Percutaneous Gastrostomy Set recalled by Cook

Cook is recalling Mallinckrodt Institute Percutaneous Gastrostomy Set, distributed nationwide in the US. The recall was initiated on 19 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesWOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495

Quantity recalled615

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0830-2018
FDA event ID: 79192
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2017
FDA classified: 1 Mar 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

19 Oct 2017	Recall initiated by company
1 Mar 2018	Classified by FDA	+133 days
7 Mar 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Product as listed by the FDA

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Which lots are affected?

WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 79192

Reported	Class	Recall	Company	Reason	Where
7 Mar 2018	CLASS II	Percutaneous Gastrojejunostomy Set recalled by Cook	Cook	Other	Nationwide
7 Mar 2018	CLASS II	Wills-Oglesby Percutaneous Gastrostomy Set recalled by Cook	Cook	Other	Nationwide

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