FDA-Device2025-04-23Class II
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ506
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
2,531 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2025Don't want to check this manually?
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