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Recall Observatory FDA recall evidence

Device product

ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the COVID-19 vaccine

Z-2081-2021

June 02, 2021

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 88122
Status
Terminated
Classification
Class II
Quantity
53,388 kits
Official record key
device-enforcement:Z-2081-2021

Official wording

Reason: Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.

Code information: All convenience kit lot numbers distributed 5/4/2021 - 5/24/2021, containing syringes as follows: a) SYRINGE/NDL, 3CC 25GX1 1/2" BD, Lot numbers: 9252960, 0296288, 9252961 b) SYRINGE/NDL, 3CC 23GX1 1/2" BD, Lot Numbers: 0324763, 0324761, 0324766, 0324770, 1015383, 1020431

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.