FDA Medical Device Recalls (openFDA)
Medline Industries Inc.: Medline CHEST TUBE REORDER NO: DYNJ36762A
- Recall number
- Z-1683-2022
- Recalling firm
- Medline Industries Inc.
- Product
- Medline CHEST TUBE REORDER NO: DYNJ36762A
- Status
- Open, Classified
- Initiated
- 2022-07-21
- Posted
- not on file
- Terminated
- not on file
- 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 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
- 300 kits
- Distribution
- U.S. Nationwide distribution in the state of AL.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRP
- Firm FEI
- 3005595283
- Firm city
- Laredo
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28