FDA Recall Terminated

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.

Recall: Z-0822-2011 · Initiated June 24, 2010

Recall

Recall Number
Z-0822-2011
Event Number
56170
Firm
Bd Medical Systems
FEI Number
3004589032
Status
Terminated
Root Cause
Process control
Initiated
June 24, 2010
Posted
December 28, 2010
Terminated
June 29, 2012
Address
411 Waverley Oaks Rd, Waltham, MA, 02452-8405

Description

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.

Reason

Blades may contain defects at the blade tip or cutting edge.

Action

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.

Distribution

Nationwide Distribution

Quantity

524 pieces