Z-0822-2011

BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main...

Name: Z-0822-2011 BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main...
Creator: Bd Medical Systems
Published: 2010-06-24
License: https://open.fda.gov/license/

BD Medical Systems / initiated 2010-06-24 / Terminated / root cause: manufacturing process

FDA source

Bd Medical Systems began a recall of 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... on 2010-06-24. The reason FDA records is "Blades may contain defects at the blade tip or cutting edge". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0822-2011
Status: Terminated
Initiated: 2010-06-24
Posted: 2010-12-28
Terminated: 2012-06-29
Recalling firm: BD Medical Systems
Product: 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 for recall: Blades may contain defects at the blade tip or cutting edge.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 524 pieces
Distribution: Nationwide Distribution
Product codes and lots: Lot #9138996 Exp: 2014-05

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)