Device product

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

Z-1109-2021

December 23, 2020

Class II

Product summary

Firm: Becton Dickinson & Company
Event: Event 87158
Status: Terminated
Classification: Class II
Quantity: 155,200 needles
Official record key: device-enforcement:Z-1109-2021

Official wording

Reason: 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.

Code information: Catalog (Ref No.) 305482 100/package UDI 00382903054824 Lot # 8142303 exp date 31-May-2023

Distribution pattern: Distribution US nationwide and Canada

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

open seal
Sterility assurance
reason.sterility_assurance · v1.0.0

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