The Recall Desk
HighFDA (Devices)·Z-2081-2021·Announced 2021-07-28

Moderna COVID-19 Vaccine Administration Kits Recalled for Unsuitable Syringes

McKesson is recalling 53,388 Moderna COVID-19 vaccine administration kits due to unsuitable 3mL syringes included in the kits. The affected kits were distributed May 4-24, 2021, and should not be used for vaccine administration.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving vaccine administration equipment. The unsuitable syringes present risk of improper vaccine delivery, which could affect immunization effectiveness. No illnesses or injuries have been reported.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling 53,388 Ancillary Adult 140-Dose Convenience Kits (Item #1189482) used for administering the Moderna COVID-19 vaccine. The kits were distributed nationwide between May 4 and May 24, 2021, and contain unsuitable 3mL syringes with conventional needles that are not appropriate for vaccine administration.

The recall affects kits containing specific syringe lot numbers: BD syringes with lot numbers 9252960, 0296288, 9252961 (25-gauge, 1.5-inch), and lot numbers 0324763, 0324761, 0324766, 0324770, 1015383, 1020431 (23-gauge, 1.5-inch).

Healthcare providers and vaccination sites that received these kits should stop using them for vaccine administration and contact McKesson or the FDA. This is a Class II FDA recall.

The recalled product

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
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • unsuitable-syringes
  • vaccine-administration-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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

Distributed nationwide across the United States.