FDA-Device2016-09-14Class II
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.
Aspen Surgical Puerto Rico Corp.
Hazard
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.
Sold states
US distribution only.
Affected count
6,000 pieces
Manufactured in
Rd 183 Km 20.3, Las Piedras, PR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2755-2016Don't want to check this manually?
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