FDA Device recall Z-1558-2021
Kit: Blood Culture
- FDA Device
- Class I
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of Kit: Blood Culture by Medical Action Industries 306, citing medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1558-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-04-09 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medical Action Industries 306 |
| Distribution | US |
Product
Kit: Blood Culture. MAI Kit Part Number: 80315D
Reason
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Identifiers
| code_info | Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expir…Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1558-2021%22
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