HIGH

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

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

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: E-Mail

Full Description

Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B. Reason: Convenience kits labeled as sterile have not gone through the sterilization process.. Classification: Class I. Quantity: 22 units. Distribution: US Distribution to States of: FL, MD, NJ, TN

Advertisement

Product Classification

Product Details

Model Numbers
1) DYNJ0382730O
UDI-DI: 10198459117992(each)
40198459117993(case)
Lot Number: 25GBC583
2) DYNJ61038B
+3 more
Affected States
FL, MD, NJ, TN
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
Advertisement

Related Recalls