| Date Initiated by Firm | October 19, 2017 |
|---|
| Create Date | March 01, 2018 |
|---|
| Recall Status1 |
Terminated 3 on April 16, 2019 |
| Recall Number | Z-0832-2018 |
|---|
| Recall Event ID |
79192 |
| Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
|
| Product | Wills-Oglesby Percutaneous Gastrostomy Set
Product Usage:
Intended for the percutaneous placement of a catheter for gastroenteric feeding |
|---|
| Code Information |
WOGS-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023 |
| FEI Number |
1820334
|
Recalling Firm/
Manufacturer |
Cook Inc.
750 N Daniels Way
Bloomington
IN
47404-9120
|
| For Additional Information Contact | Larry Pool
812-339-2235 |
|---|
Manufacturer Reason
for Recall | Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | Quantities co-mingled into line 1 |
|---|
| Distribution | US Nationwide Distribution |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
