FDAHealthAugust 8, 2025
Medline Industries, LP — 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.
Is this relevant to me?
- Geography
- US, FL, MD, NJ, TN
- Source agency
- FDA
- Category
- Health
- Published
- August 8, 2025
US Distribution to States of: FL, MD, NJ, TN
What's affected?
- Product
- Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
- Lot code
- 25GBC583
Additional details
1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 22 units.
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