FDAFDA · Food and drugs·Recall number Z-0830-2018
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Published March 7, 2018 · Recall initiated: October 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Inc.
- Distributor
- US Nationwide Distribution
- Lot
- WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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