—#187938

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

FDA product code: QMT — Prep Kit Vaccine Injection
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2021-06-02
Terminated: 2022-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187938. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.