Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B...
FDA Recall #Z-2755-2016 — Class II — June 27, 2016
Product Description
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.
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.
Recalling Firm
Aspen Surgical Puerto Rico Corp. — Las Piedras, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6,000 pieces
Distribution
US distribution only.
Code Information
LOT 0088464
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated