Recalls / —

—#81923

Product

BD 20 ml Syringe Luer-Lok Tip Sterile, Do not reuse; Catalog Number 309661.

FDA product code

FMF — Syringe, Piston

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

Catalog Number 309661: Lot numbers: 9065361, 9065362, 9065366, 9065367, 9065380.

Why it was recalled

Potential for compromised sterility: Insufficient packaging seals.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Becton Dickinson sent Urgent Product Recall letters on April 30, 2009 to all direct customers. Questions are to be directed to BD Customer Service at 1-888-237-2762. Letters to customers of distributors went out on May 12, 2009.

Recalling firm

Firm

Becton Dickinson & Company

Address

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

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2009-04-30

Posted by FDA

2009-06-24

Terminated

2009-09-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #81923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.