Skip to content
Recall Observatory FDA recall evidence

Device product

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B

Z-2592-2025

August 08, 2025

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 97495
Status
Ongoing
Classification
Class I
Quantity
22 units
Official record key
device-enforcement:Z-2592-2025

Official wording

Reason: Convenience kits labeled as sterile have not gone through the sterilization process.

Code information: 1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;

Distribution pattern: US Distribution to States of: FL, MD, NJ, TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Convenience kits labeled as sterile have not gone through the sterilization process.