Recalls / —

—#43269

Product

BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder.

FDA product code

KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components

Device class

Class 2

Medical specialty

Hematology

510(k) numbers

K011984

Affected lot / code info

Catalog # -- Lot #:  367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936.

Why it was recalled

Cracked finger grip luer adapter components on the Push Button Blood Collection Set.

Root cause (FDA determination)

Other

Action the firm took

Recall notification was sent out to the customers on 12/5/2005.

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern

The device was shipped to 23 wholesalers, 5 hospitals, and 1 VA govt. account nationwide.

Timeline

Recall initiated

2005-12-01

Posted by FDA

2006-01-11

Terminated

2007-04-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #43269. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.