Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving sterile medical devices used in surgical procedures (chest tube insertion, hernia repair). The potential compromise of sterility assurance level on surgical kits presents a significant risk of infection and harm, meeting the Class II with significant injury/harm-risk threshold for a Severe rating.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, including the Chest Tube Insertion Tray (Model DYNDA2941A), Chest/Breast-LF (Model DYNJ83950), and Hernia Repair Tote (Models DYNJ908337A and DYNJ908337C). A total of 892 units have been distributed nationwide.
The recall was initiated because of calibration issues identified in the equipment used to sterilize and package these devices. While all products were exposed to validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities and individuals who received these kits should immediately contact Medline Industries for guidance on next steps. The specific lot numbers affected are detailed in the recall notice.
The recalled product
- Product
- Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 892
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYNDA2941A
- UDI-DI: 10195327331795(each)
- 40195327331796(case)
- Lot Number: 23BMB940
- 2) DYNDA2941A
- Lot Number: 23FMF503
- 3) DYNJ83950
- UDI-DI: 10195327318925(each)
- 40195327318926(case)
- Lot Number: 23CBG610
- 4) DYNJ83950
- Lot Number: 23FBF248
- 5) DYNJ83950
- Lot Number: 23LBR075
- 6) DYNJ83950
- Lot Number: 24CBH626
- 7) DYNJ83950
- Lot Number: 24DBT832
- 8) DYNJ908337A
- UDI-DI: 10195327524814(each)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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