Recall Z-2755-2016— Aspen Surgical Puerto Rico Corp.
Class II · Terminated
Class II FDA medical device recall by Aspen Surgical Puerto Rico Corp., initiated 2016-06-27, terminated 2017-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Aspen Surgical Puerto Rico Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-27
- Terminated
- 2017-05-15
- Firm location
- Las Piedras, PR, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.