Z-2081-2021 Class II Terminated
FDA device recall Z-2081-2021 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Jun 2, 2021 and is designated Class II. Reason for recall: Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits. The recall status is terminated (terminated Apr 28, 2022). Affected quantity: 53,388 kits.
Recall details
- Product Type
- Devices
- Report Date
- Jul 28, 2021
- Initiation Date
- Jun 2, 2021
- Termination Date
- Apr 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,388 kits
Product description
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
Reason for recall
Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.
Distribution pattern
US Nationwide Distribution
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2081-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026