Recall Z-1683-2022 ยท LRP Tray, Surgical
Medline Industries Inc.
Medline CHEST TUBE REORDER NO: DYNJ36762A
| Date | Jul 21, 2022 |
| Status | Open, Classified |
| Reason | Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit |
| Root cause | Process control |
| Action | On 07/21/2022, Medline Industries, LP send an "IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL" Letter via first class mail and email to customers informing them that due to the non-sterile Elastic Adhesive Tape component being placed into the sterile portion of the kit. Placement of this component results in the loss of sterility. Required Action: 1.Immediately check their stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. 2.Please use the link and the information below to complete the response form. Please list the quantit |
| Quantity | 300 kits |
| Distribution | U.S. Nationwide distribution in the state of AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.