---
title: "SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 — FDA record Z-0789-2022 | Is It on Recall"
description: "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 c"
url: https://isitonrecall.com/recall/fda-device-z-0789-2022-sam-chest-seal-ref-cs203-en-combo-lot-y060321-09/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 — FDA record Z-0789-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Sam Medical Products
- **Quantity**: 2,950 packages
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0789-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0789-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Rhode Island](https://isitonrecall.com/state/rhode-island/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Mar 23, 2022
- **Recall initiation date**: Jan 28, 2022
- **Center classification date**: Mar 16, 2022
- **Termination date**: Apr 6, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0789-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Sam Medical Products records](https://isitonrecall.com/brand/sam-medical-products/)