Recall Z-0830-2018— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2017-10-19, terminated 2019-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding. Reason: Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-19
- Terminated
- 2019-04-16
- Firm location
- Bloomington, IN, United States
Product description
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Reason for recall
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Data sourced from openFDA. This site is unofficial and independent of the FDA.