| Date Initiated by Firm | October 23, 2017 |
|---|
| Create Date | March 17, 2018 |
|---|
| Recall Status1 |
Terminated 3 on June 21, 2018 |
| Recall Number | Z-1078-2018 |
|---|
| Recall Event ID |
79329 |
| Product Classification |
Suture removal kit - Product Code MCZ
|
| Product | SKIN STAPLE REMOVER |
|---|
| Code Information |
44105 Lot codes: 2015083101 2016101701 2017082801 2017030601 2016072501 |
Recalling Firm/
Manufacturer |
Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
|
Manufacturer Reason
for Recall | Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | On October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall. |
|---|
| Distribution | Nationally |
|---|
| 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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