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Recall Observatory FDA recall evidence

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