FDA Recall Terminated

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

Recall: Z-1892-2018 · Initiated November 6, 2017

Recall

Recall Number
Z-1892-2018
Event Number
80074
Firm
Southmedic, Inc.
FEI Number
3001717360
Product Code
GDX
Status
Terminated
Root Cause
Process control
Initiated
November 6, 2017
Terminated
April 2, 2020
Address
50 Alliance Blvd, Barrie Canada

Description

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

Reason

Scalpels lot contains non-sterile products labeled as sterile.

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 appreciated. We apologize for any inconvenience this action may cause. Your immediate attention is appreciated. For product return questions please contact Customer Service at (800) 463- 7146 ext 307.

Distribution

US Distribution to the states of : IA, IL, NE, NY and TX

Quantity

3,300 scalpels