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U.S. Department of Health and Human Services

Class 2 Device Recall BD Beaver Slit Blade 3.0mm Straight

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 Class 2 Device Recall BD Beaver Slit Blade 3.0mm Straightsee related information
Date Initiated by FirmJune 24, 2010
Date PostedDecember 28, 2010
Recall Status1 Terminated 3 on June 29, 2012
Recall NumberZ-0822-2011
Recall Event ID 56170
ProductBD 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.
Code Information Lot #9138996 Exp: 2014-05
FEI Number 3004589032
Recalling Firm/
Manufacturer		 Bd Medical Systems
411 Waverley Oaks Rd
Waltham MA 02452-8405
Manufacturer Reason
for Recall		Blades may contain defects at the blade tip or cutting edge.
FDA Determined
Cause 2		Process control
ActionBD 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.
Quantity in Commerce524 pieces
DistributionNationwide Distribution
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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