ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration of the Moderna COVID-19 vaccine conv
Summary
The FDA issued a Class II for ANCILLARY ADULT 140-DOSE CONVENIENCE KIT, ITEM #1189482, for the administration by Mckesson Medical-Surgical Inc. Corporate Office. Reason: Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits..
Details
Source
Device Recall
External ID
Z-2081-2021
Action Date
2021-07-28
Status
Terminated
Category
device
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
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
Quantity Affected: 53,388 kits
Reason for Recall
Two unsuitable 3mL syringes with conventional needles for vaccine administration included in some Moderna 140 Ancillary Convenience Kits.
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-02
Company
Richmond, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2081-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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