—#185456

Product

BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023

Why it was recalled

The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.

Root cause (FDA determination)

Process control

Action the firm took

On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distribution US nationwide and Canada

Timeline

Recall initiated: 2020-12-23
Terminated: 2022-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185456. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.