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Recall Observatory FDA recall evidence

Device product

BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822

Z-0179-2022

September 27, 2021

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 88805
Status
Terminated
Classification
Class II
Quantity
8,000 units
Official record key
device-enforcement:Z-0179-2022

Official wording

Reason: Holes in product packaging impacts package integrity and may compromise sterility.

Code information: Lot Number: 1111347 Exp. Date: 4/30/2026 UDI: 10382903058225

Distribution pattern: TX

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging impacts package integrity and may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging impacts package integrity and may compromise sterility