| Date Initiated by Firm | March 29, 2019 |
|---|
| Create Date | June 04, 2019 |
|---|
| Recall Status1 |
Terminated 3 on May 08, 2020 |
| Recall Number | Z-1719-2019 |
|---|
| Recall Event ID |
82667 |
| Product Classification |
General wellness product - Product Code PWC
|
| Product | Sterile Nail Clipper Concave Edge (67710) |
|---|
| Code Information |
Lot 2018120701, exp 2023-11-30 |
| FEI Number |
3008403546
|
Recalling Firm/
Manufacturer |
Centurion Medical Products Corporation
100 Centurion Way
Williamston
MI
48895-9086
|
| For Additional Information Contact | Lisa A. Carpenter
517-546-5400 Ext. 1156 |
|---|
Manufacturer Reason
for Recall | Compromised seal on the sterile barrier pouch. |
|---|
FDA Determined
Cause 2 | Packaging |
|---|
| Action | On March 29, 2019, Centurion issued URGENT PRODUCT RECALL NOTICES to customers via courier service. Customers were advised to take the following actions:
1) Inspect stock and quarantine product
2) Discontinue use of product immediately
3) Complete and return the accountability record via fax to 517-546-3356 or via email to Lcarpenter@centurionmp.com |
|---|
| 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.
|
