Recall Z-0789-2022 ยท NAD Dressing, Wound, Occlusive
Sam Medical Products
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
| Date | Jan 28, 2022 |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL Sam Medical Products, Mar 3, 2011 |