FDA Enforcement
Class II
Terminated
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.
Recall: Z-2755-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2755-2016
- Event ID
- 74584
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Aspen Surgical Puerto Rico Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 14, 2016
- Initiation Date
- June 27, 2016
- Classification Date
- September 8, 2016
- Termination Date
- May 15, 2017
- Address
- Rd 183 Km 20.3, Las Piedras, PR, 00771, United States
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
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 Info
LOT 0088464
Distribution
US distribution only.
Quantity
6,000 pieces