Medical device recalls Moderate risk

Aspen Surgical Puerto Rico Corp. recalls Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***…

Recall date
June 27, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2755-2016
FDA classification
Class II
Brand / firm
Aspen Surgical Puerto Rico Corp.
Sold / distributed
US distribution only.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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