Z-1683-2022Class II

Medline CHEST TUBE REORDER NO: DYNJ36762A

Name: Z-1683-2022 Medline CHEST TUBE REORDER NO: DYNJ36762A
Creator: Medline Industries Inc.
Published: 2022-07-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-07-21 / Open, Classified / root cause: manufacturing process

FDA source

Medline Industries Inc. began a recall of Medline CHEST TUBE REORDER NO: DYNJ36762A on 2022-07-21. FDA classified it as Class II and gives the reason as "Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1683-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-21
Posted: 2022-09-07
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline CHEST TUBE REORDER NO: DYNJ36762A
Product code: LRP Tray, Surgical
Reason for recall: Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
Root cause tag: manufacturing process
FDA 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 in commerce: 300 kits
Distribution: U.S. Nationwide distribution in the state of AL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1683-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1683-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-14	2022-09-07

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)