Recalls / —

—#49828

Product

BD Beaver Mini-Blade, Blade Mini RND Tip Sharp One Side, Catalog Number: 376400

FDA product code

HNN — Knife, Ophthalmic

Device class

Class 1

Medical specialty

Ophthalmic

Affected lot / code info

Lot Numbers: 6138940, 6146142, 6156739, 6166196, 6167300, 6172592, 6177437, 6186449, 6191356, 6193323, 6195540, 6200787, 6205116, 6212332, 6215951, 6222023, 6228063, 6233806, 6241023, 6255156, 6262012, 6269131, 6278501 6296135* 6300614* 6312509* 6331680* 6338257* 6346693*

Why it was recalled

Product sterility may be compromised due to incomplete package seal

Root cause (FDA determination)

Other

Action the firm took

On 12/26/2006 BD Medical, Ophthalmic Systems mailed a recall notification letter to US Distributors and US OEM''s. Customers are instructed to return any affected products to BD for a replacement. On 1/10/07, the firm expanded the recall to additional lots. Those lots are noted with an asterisk.

Recalling firm

Firm

Becton Dickinson and Company

Address

411 Waverley Oaks Rd, Ste 2229, Waltham, Massachusetts 02452-8448

Distribution

Distribution pattern

Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.

Timeline

Recall initiated

2006-12-26

Posted by FDA

2007-02-08

Terminated

2016-03-07

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49828. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.