FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
- Recall number
- Z-2593-2025
- Recalling firm
- Medline Industries, LP
- Product
- Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
- Status
- Open, Classified
- Initiated
- 2025-08-08
- Posted
- 2025-09-26
- Terminated
- not on file
- Reason
- Convenience kits labeled as sterile have not gone through the sterilization process.
- Root cause
- Process control
- Action
- Customers were alerted via email and telephone beginning 8/8/25 of a potential issue with the products. An URGENT MEDICAL DEVICE RECALL notification letter dated 8/22/25 was sent to customers. This communication is a follow-up to the notification you received from your Medline Sales Representative and to acknowledge the subsequent return of impacted product to Medline. This communication is to provide formal documentation of the recall for your records. No additional action is required to be taken. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Sterile Medline Convenience Kits. It has been identified that specific convenience kits labeled as sterile have not gone through the sterilization process. As a result, these kits are non-sterile. If the non-sterile kits are assumed sterile upon use, this could result in potential contamination of the sterile-field and an increased risk of patient infection that may require the use of intravenous or oral antibiotics. Refer to the enclosed list for all affected item number(s) and affected lot number(s). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax and to Medline Industries, LP. If you have any questions regarding this notification, please contact the Director, Regulatory Compliance at (smbrandel@medline.com). or Product Recall Specialist at HBarclay@Medline.com.
- Quantity
- 88 units
- Distribution
- US Distribution to States of: FL, MD, NJ, TN
- Lot, serial or model codes
- 1) DYNJ45701B, UDI-DI: 10193489856279(each), 40193489856270(case), Lot Number: 25GBF686
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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