Z-2592-2025Class I
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-08-08 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B on . FDA classified it as Class I and gives the reason as "Convenience kits labeled as sterile have not gone through the sterilization process". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2592-2025
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
- Product code
- LRO General Surgery Tray
- Reason for recall
- Convenience kits labeled as sterile have not gone through the sterilization process.
- Root cause tag
- manufacturing process
- FDA 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 ([email protected]). or Product Recall Specialist at [email protected].
- Quantity in commerce
- 22 units
- Distribution
- US Distribution to States of: FL, MD, NJ, TN
- Product codes and lots
- 1) DYNJ0382730O, UDI-DI: 10198459117992(each), 40198459117993(case), Lot Number: 25GBC583; 2) DYNJ61038B, UDI-DI: 10195327596316(each), 40195327596317(case), Lot Number: 25GBF720;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2592-2025 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2593-2025 | Class I | Ongoing | Voluntary: Firm initiated |
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