Recall Z-0789-2022— Sam Medical Products

Name: FDA recall Z-0789-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-28

Class II · Terminated

Class II FDA medical device recall by Sam Medical Products, initiated 2022-01-28, terminated 2023-04-06. It names one FDA 510(k) clearance: K102403. 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..

Recalling firm: Sam Medical Products
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Terminated: 2023-04-06
Firm location: Tualatin, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K102403 — SAM CHEST SEAL WITH VAVLESam Medical Products·cleared 2011-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.