Date Initiated by Firm | July 21, 2022 |
Create Date | September 07, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1683-2022 |
Recall Event ID |
90689 |
Product Classification |
Tray, surgical - Product Code LRP
|
Product | Medline CHEST TUBE REORDER NO: DYNJ36762A |
Code Information |
Model Number: DYNJ36762A
UDI-DI Code (GTIN Insert/GTIN Case / Lot Number:
(01)1019348989440/(01)40193489894401 / 21ILA164
(01)1019348989440/(01)40193489894401 / 21ILA986
(01)1019348989440/(01)40193489894401 / 21JLA315
(01)1019348989440/(01)40193489894401 / 21KLA005
(01)1019348989440/(01)40193489894401 / 21KLA162
(01)1019348989440/(01)40193489894401 / 21KLA629
|
Recalling Firm/ Manufacturer |
Medline Industries Inc. 12001 General Milton Laredo TX 78045
|
For Additional Information Contact | Karin Johnson 866-359-1704 |
Manufacturer Reason for Recall | Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 300 kits |
Distribution | U.S. Nationwide distribution in the state of AL. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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