Medline Convenience Kits Recalled for Potential Packaging Seal Defect
Medline has recalled two models of convenience kits due to potential open or weak seals on packaging breather pouches. Approximately 530 units distributed worldwide may be affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall involving potential compromise of sterile packaging barriers. No illnesses or injuries have been reported, but the hazard affects sterile medical supplies where barrier breach presents a risk of contamination.
Plain-English summary
Medline Industries, LP has recalled two models of convenience kits used for medical procedures: the T&A ENDO PACK (Model DYNJ59620A) and TRAY ADD A CATH FOL UM MF 10ML (Model DYND150200S). Approximately 530 units have been affected by this recall.
The recalled kits contain breather pouches used for packaging and sterilization. Some of these pouches may have open or weak seals, which could compromise the sterile barrier that protects the medical supplies inside.
The affected units were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. The specific affected lot numbers are 24KBH321 (for Model DYNJ59620A) and 24KBK308 (for Model DYND150200S).
Healthcare facilities and users who have received kits with these lot numbers should not use them. Contact Medline Industries, LP (Northfield) for instructions on return or destruction of the affected kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kits
- Hazard
- weak-seals
- sterile-barrier-breach
- contamination-risk
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 (8)
- 1) DYNJ59620A
- UDI-DI: 10193489685367(each)
- 40193489685368(case)
- Lot Number: 24KBH321
- 2) DYND150200S
- UDI-DI: 10195327387884(each)
- 40195327387885(case)
- Lot Number: 24KBK308
Distribution
Distributed nationwide across the United States.
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