Recall Z-1078-2018 ยท MCZ Suture Removal Kit
Centurion Medical Products Corporation
SKIN STAPLE REMOVER
| Date | Oct 23, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.