Recalls / —
—#161572
Product
Wills-Oglesby 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-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023
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 #161572. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.