FDA Device recall Z-1557-2021
Kit: LVAD Dres Chg
- FDA Device
- Class I
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class I recall of Kit: LVAD Dres Chg 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-1557-2021 |
| 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: LVAD Dres Chg. MAI Kit Part Number: 79544B
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: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022) |
|---|
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-1557-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.