Medline CHEST TUBE REORDER NO: DYNJ36762A
Recall
- Recall Number
- Z-1683-2022
- Event Number
- 90689
- Firm
- Medline Industries Inc. 12001 General Milton
- FEI Number
- 3005595283
- Product Code
- LRP
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- July 21, 2022
- Address
- Laredo, TX, 78045
Description
Medline CHEST TUBE REORDER NO: DYNJ36762A
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
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 quantity of affected product in their inventory on the form. Even if customers do not have any affected product in inventory, please complete and submit the form. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-22-094-FG Recall Code: RXXXXXXX 3.Upon completion of the form, please destroy affected product. Customer's account will receive credit once the response form is submitted. 4.If customer is a distributor, or has resold or transferred this product to another company or individual, customer is required by FDA regulations to notify them of this recall communication. Have the customers document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704.
U.S. Nationwide distribution in the state of AL.
300 kits