Food, drugs, devices › Cook Inc.
Device recall: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter
FDA enforcement event 79192 is a device recall by Cook Inc. of Bloomington, IN, initiated 19 Oct 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 16 Apr 2019. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Inc., Bloomington, IN.
Reason for recall
"Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0830-2018 | Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding | 615 | Class II | Terminated | 7 Mar 2018 |
| Z-0831-2018 | Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding | Quantities co-mingled into line 1 | Class II | Terminated | 7 Mar 2018 |
| Z-0832-2018 | Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding | Quantities co-mingled into line 1 | Class II | Terminated | 7 Mar 2018 |
Context
Other enforcement events for Cook Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Apr 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.