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U.S. Department of Health and Human Services

Class 2 Device Recall Southmedic Sterile Disposable Scalpel Rx only

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 Class 2 Device Recall Southmedic Sterile Disposable Scalpel Rx onlysee related information
Date Initiated by FirmNovember 06, 2017
Create DateMay 17, 2018
Recall Status1 Terminated 3 on April 02, 2020
Recall NumberZ-1892-2018
Recall Event ID 80074
Product Classification Scalpel, one-piece - Product Code GDX
ProductSouthmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Code Information Part Number 73-0115 Lot Number 092517
FEI Number 3001717360
Recalling Firm/
Manufacturer		 Southmedic, Inc.
50 Alliance Blvd
Barrie Canada
For Additional Information ContactGenna Woodrow
800-463-7146 Ext. 307
Manufacturer Reason
for Recall		Scalpels lot contains non-sterile products labeled as sterile.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce3,300 scalpels
DistributionUS Distribution to the states of : IA, IL, NE, NY and TX
Total Product Life CycleTPLC 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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