Recalls / —

—#40378

Product

#309661 -- Syringe only ll 20 mL

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K980987

Affected lot / code info

309661 Syringe only LL 20 ML 5061527; 309661 Syringe only LL 20 ML 5047172

Why it was recalled

The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

Root cause (FDA determination)

Other

Action the firm took

BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery.

Recalling firm

Firm

Becton Dickinson & Company

Address

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

Distribution

Distribution pattern

BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics.

Timeline

Recall initiated

2005-05-25

Posted by FDA

2005-07-28

Terminated

2005-12-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40378. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.