FDA Device recall Z-0783-2021
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdomin…
- FDA Device
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdomin… by Medline Industries, citing the cylindrical sponge component is not x-ray detectable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0783-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-13 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries |
| Distribution | n/a |
Product
Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Reason
The cylindrical sponge component is not x-ray detectable.
Identifiers
| code_info | Lot 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022) |
|---|
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-0783-2021%22
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