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Recall Observatory FDA recall evidence

Device product

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.

Z-2755-2016

June 27, 2016

Class II

Product summary

Firm
Aspen Surgical Puerto Rico Corp.
Event
Event 74584
Status
Terminated
Classification
Class II
Quantity
6,000 pieces
Official record key
device-enforcement:Z-2755-2016

Official wording

Reason: 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.

Code information: LOT 0088464

Distribution pattern: US distribution only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.