Reported Mar 7, 2018 · Terminated
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a…
Cook Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Mallinckrodt Institute Percutaneous
- Gastrostomy Set Product UsageIntended for the percutaneous placement of a catheter for gastroenteric feeding
- Lot codes and dates
- WOGS-1400 -MKOT-A Lot numbers
68693156908857703466171060577193431725231776356977744001781158780252208076495
- WOGS-1400 -MKOT-A Lot numbers
- Amount recalled
- 615
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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