FDA Device recall Z-0789-2022
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
- FDA Device
- Class II
- terminated
- Published 2022-03-23
On 2022-03-23 the FDA classified a Class II recall of SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 by Sam Medical Products, citing due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0789-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-01-28 |
| Published | 2022-03-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sam Medical Products |
| Distribution | AZ, CA, CO, FL, GA, MA, NY, OR, PA, PR, RI, TX, VA, WA |
Product
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Reason
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
Identifiers
| code_info | Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)1082204500019…Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)10822045000193(10)Y060321-09(17)270601 (Each Pouch/Package) Lot Number: Y060321-09 |
|---|
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-0789-2022%22
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