Recall Z-0830-2018 ยท KNT Tubes, Gastrointestinal (And Accessories)
Cook Inc.
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
| Date | Oct 19, 2017 |
| Status | Terminated |
| Reason | Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. |
| Root cause | Under Investigation by firm |
| Action | On October 19, 2017 an URGENT MEDICAL DEVICE RECALL letter was mailed to customers requesting that they examine inventory for affected product, immediately quarantine and return product to recalling firm for credit. Questions or concerns can be directed to 1-800-457-4500 or 812-330-2235. |
| Quantity | 615 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.