Z-2081-2021Class II

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

Name: Z-2081-2021 ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19...
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2021-06-02
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2021-06-02 / Terminated

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a recall of ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine convenience kit for the administration of the... on 2021-06-02. FDA classified it as Class II and gives the reason as "Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2081-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-02
Posted: 2021-07-16
Terminated: 2022-04-28
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
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
Product code: QMT Prep Kit – Vaccine Injection
Reason for recall: Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.
FDA root cause: Process change control
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.
Quantity in commerce: 53,388 kits
Distribution: US Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-28	2021-07-16

Product code QMT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)