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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.

FDA Recall Z-1892-2018 · Posted None

Recalling FirmSouthmedic, Inc.
Recall StatusTerminated
Product CodeGDX
Date Initiated2017-11-06
Date Terminated2020-04-02
Product Quantity3,300 scalpels

Reason for Recall

Scalpels lot contains non-sterile products labeled as sterile.

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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