Z-0789-2022Class II

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Name: Z-0789-2022 SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Creator: Sam Medical Products
Published: 2022-01-28
License: https://open.fda.gov/license/

Sam Medical Products / initiated 2022-01-28 / Terminated / root cause: manufacturing process

FDA source

Sam Medical Products began a recall of SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 on 2022-01-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0789-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Posted: 2022-03-16
Terminated: 2023-04-06
Recalling firm: Sam Medical Products
Product: SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Product code: NAD Dressing, Wound, Occlusive
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/27/2022, the firm sent a "MEDICAL DEVICE RECALL" letter via signature required parcel service to distributors and direct internet customers informing them that the chest seal combo package may contain an occlusive dressing that has a hole in the center which would prevent the dressing from performing as an occlusive chest seal. Instructions to: For Distributors - 1. Indicate with a Yes or No response that you have received the SAM Chest Seal Combo Recall Notification (by signature required UPS delivery, email, fax or by phone) and understand the instructions from the Recall Notification. 2. Indicate with a Yes or No response if there have been any complaints or adverse events reported to you regarding the recalled product. If there was a report that a SAM Chest Seal Combo was not able to be used on a patient, please report the details on the Recall Response Form. 3. Affected Product Information - Information on the quantity of recalled devices shipped to your facility and the date the devices were shipped from SAM Medical is included on the Recall Response Form. - Quantity in Inventory Number of recalled SAM Chest Seal Combo products currently in your possession. - Quantity to Return This could be the same as the Quantity in Inventory but could include devices already returned from the sub-distributor or end user. - Quantity Used or Destroyed This is the number of recalled devices that have been used on patients, used in product demonstrations or in training events. - Quantity Further Distributed This is the number of recalled devices that you have sold to Sub-distributors and Direct Customers. 4. Distributor Information Place a mark the in the check box next to each of the statements that are applicable to you as a Distributor. 5. Complete the form by applying your Signature and the date the form was signed, print your name, company affiliation, phone number and email address. Return this Recall Response form to SAM Medical by Fax (503-
Quantity in commerce: 2,950 packages
Distribution: U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0789-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-23	2022-03-16

Product code NAD

K102403Class ISam Chest Seal with Vavle; Sam Chest SealSam Medical Products / cleared 2011-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)