Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
FDA Recall Z-2755-2016 · Posted 2016-09-08
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Recalling FirmAspen Surgical Puerto Rico Corp.
Recall StatusTerminated
Product CodeGES
Date Initiated2016-06-27
Date Terminated2017-05-15
Product Quantity6,000 pieces
Reason for Recall
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
Firm Action
An "Urgent: Medical Device Correction" letter was sent on June 27, 2016. The letter provided background on the issue, as well as actions to be taken by the user. Customers have the alternative to either keep the product or return it for replacement. A response form was included for customers to complete and return. Customers are to maintain awareness of the incorrect identification prior to use. Questions concerning the correction can be directed to [email protected].
Root Cause
Mixed-up of materials/components
Distribution Pattern
US distribution only.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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