FDA-Device2025-10-08Class I
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Hazard
Convenience kits labeled as sterile have not gone through the sterilization process.
Sold states
US Distribution to States of: FL, MD, NJ, TN
Affected count
22 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2025More Medline Industries, LP recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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