BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.
This recall has been terminated (originally issued December 28, 2010).
- Company
- Bd Medical Systems
- Recall Initiated
- June 24, 2010
- Posted
- December 28, 2010
- Terminated
- June 29, 2012
- Recall Number
- Z-0822-2011
- Quantity
- 524 pieces
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Blades may contain defects at the blade tip or cutting edge.
Distribution
Nationwide Distribution
Lot / Code Info
Lot #9138996 Exp: 2014-05
Root Cause
Process control
Action Taken
BD Medical notified customers via letter dated 6/24/10 to discontinue use of product and remove from inventory. Customers were instructed to complete the customer response form and fax to BD Medical. BD Medical was to contact customers upon receipt of the customer response form to arrange for replacement. Unused product was to be returned to: BD Medical Ophthalmic Systems Attn: WT-12582 411 Waverly Oaks Road Building 2, Suite 229 Watham, Massachusetts 02452-8402 For questions regarding this recall call 1-781-906-7952.