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Terminated

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

FDA Recall Z-2081-2021 · Posted None

Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Recall StatusTerminated
Product CodeQMT
Date Initiated2021-06-02
Date Terminated2022-04-28
Product Quantity53,388 kits

Reason for Recall

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

Firm Action

McKesson issued an "URGENT MEDICAL DEVICE SAFETY ALERT" on 06/02/2021 by email to its consignees. The notice requested that the consignees do the following: -examine their inventory immediately to determine if you have any quantities of the product, -Immediately stop using these syringes with 3mI syringes with conventional needles for the administration of the Moderna COVID-19 vaccine. -As these 3mI syringes with conventional needles can be utilized for a variety of other uses, such as medication mixing in healthcare settings, you may continue to use these 3mI syringes with conventional needles in your healthcare facility for other appropriate uses. -Please fill out and return the Medical Device Alert Response Form attached. The firm would be shipping replacement safety syringes. For questions about this notification, please call 877-546-5661.

Root Cause

Process change control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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