FDA Medical Device Recalls (openFDA)
Mckesson Medical-Surgical Inc. Corporate Office: 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
- Recall number
- Z-2081-2021
- 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
- Status
- Terminated
- Initiated
- 2021-06-02
- Posted
- not on file
- Terminated
- 2022-04-28
- Reason
- Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.
- 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
- 53,388 kits
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QMT
- Firm FEI
- 3004386693
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28