FDA-Device2025-04-23Class II
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;
MEDLINE INDUSTRIES, LP - Northfield
Hazard
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Affected count
1098 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1614-2025Don't want to check this manually?
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