FDA Medical devices recall ·
Medline Convenience kits used for various procedures: 1) ED CRASH… recall
- Recall number
- Z-1614-2025
- Date
- (initiated March 3, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1098 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281
Why was it recalled?
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) MNS13635A, UDI-DI: 10653160994244(each), 40653160994245(case), Lot Number: 24IBH747; 2) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM309; 3) OBK387M, UDI-DI: 10889942686810(each), 40889942686811(case), Lot Number: 24JBM385; 4) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24JBM576; 5) DYNJ40573A, UDI-DI: 10888277988514(each), 40888277988515(case), Lot Number: 24JBM871; 6) CDS983998C, UDI-DI: 10193489776713(each), 40193489776714(case), Lot Number: 24JBS915; 7) DYNJ64300A, UDI-DI: 10193489852370(each), 40193489852371(case), Lot Number: 24JBU461; 8) DYNJ55205, UDI-DI: 10889942532803(each), 40889942532804(case), Lot Number: 24JBV449; 9) DYNJ56550, UDI-DI: 10889942671779(each), 40889942671770(case), Lot Number: 24JBV561; 10) DYNJ83507, UDI-DI: 10195327273071(each), 40195327273072(case), Lot Number: 24JBX835; 11) DYNJ83248, UDI-DI: 10195327248383(each), 40195327248384(case), Lot Number: 24KBF051; 12) DYNJ81281, UDI-DI: 10195327103620(each), 40195327103621(case), Lot Number: 24KBG874
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1614-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.