Recalls / —
—#161569
Product
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
- FDA product code
- KNT — Tubes, Gastrointestinal (And Accessories)
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495
Why it was recalled
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Cook Inc.
- Address
- 750 N Daniels Way, Bloomington, Indiana 47404-9120
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2017-10-19
- Terminated
- 2019-04-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161569. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.