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Recall Observatory FDA recall evidence

Device product

BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

Z-0252-2020

March 07, 2019

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 82351
Status
Terminated
Classification
Class II
Quantity
2,624,160 (2,169,703 US; 454,457 OUS)
Official record key
device-enforcement:Z-0252-2020

Official wording

Reason: BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

Code information: Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765

Distribution pattern: Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.