Class 2 Device Recall SAM Chest Seal

• Date Initiated by Firm: January 28, 2022
• Create Date: March 16, 2022
• Recall Status: Terminated on April 06, 2023
• Recall Number: Z-0789-2022
• Recall Event ID: 89510
• 510(K)Number: K102403
• Product Classification: Dressing, wound, occlusive - Product Code NAD
• Product: SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
• Code Information: 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
• Recalling Firm/ Manufacturer: Sam Medical Products; 12200 SW Tualatin Rd Suite 200; Tualatin OR 97062
• For Additional Information Contact: Marla Sandberg; 503-783-6921
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NAD and Original Applicant = SAM MEDICAL PRODUCTS