Recall Z-1892-2018 ยท GDX Scalpel, One-Piece
Southmedic, Inc.
Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
| Date | Nov 6, 2017 |
| Status | Terminated |
| Reason | Scalpels lot contains non-sterile products labeled as sterile. |
| Root cause | Process control |
| Action | On November 6th, 2017 , Southmedic sent notification to all their customers stating that: Southmedic Inc. is conducting a voluntary recall of a specific lot number of the Southmedic Sterile Disposable Scalpel (73-0115) Lot#: 092517 due to an incorrect sterility status having been identified on the label. This may result in non-sterile products being labeled as sterile. After checking your inventory, please complete the attached Voluntary Recall Notification Confirmation Form and fax to (705) 728 9537. We apologize for any inconvenience this action may cause. Your immediate attention is appr |
| Quantity | 3,300 scalpels |
| Distribution | US Distribution to the states of : IA, IL, NE, NY and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.