Z-2755-2016 Class II Terminated
FDA device recall Z-2755-2016 was initiated by Aspen Surgical Puerto Rico Corp. on June 27, 2016 and is designated Class II. 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 … The recall status is terminated (terminated May 15, 2017). Affected quantity: 6,000 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- June 27, 2016
- Termination Date
- May 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,000 pieces
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.
Distribution Pattern
US distribution only.
Code Information
LOT 0088464