| Date Initiated by Firm | October 19, 2017 |
|---|
| Create Date | March 01, 2018 |
|---|
| Recall Status1 |
Terminated 3 on April 16, 2019 |
| Recall Number | Z-0830-2018 |
|---|
| Recall Event ID |
79192 |
| Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
|
| Product | Mallinckrodt Institute Percutaneous Gastrostomy Set
Product Usage:
Intended for the percutaneous placement of a catheter for gastroenteric feeding |
|---|
| Code Information |
WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495 |
| 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 | 615 |
|---|
| 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.
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