medical Class II Updated 2025-04-23

MEDLINE INDUSTRIES, LP - Northfield recalls Medline Convenience kits used for various procedures: 1) PE

Recalled Product

Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PERI GYN, Model Number: DYNJ67708A; 6) HYSTEROSCOPY PACK, Model Number: DYNJ56417C; 7) HYSTEROSCOPY PACK CKHA-LF, Model Number: DYNJ51956B; 8) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B

Hazard / Issue

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 1) DYNJ80786, UDI-DI: 10195327079451(each), 40195327079452(case), Lot Number: 24IBH305; 2) DYNJ21937J, UDI-DI: 10195327694876(each), 40195327694877(case), Lot Number: 24JBN378; 3) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24JBT902; 4) DYNJ21824R, UDI-DI: 10195327107758(each), 40195327107759(case), Lot Number: 24JBU465; 5) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 24JBV636; 6) DYNJ56417C, UDI-DI: 10195327468804(each), 40195327468805(case), Lot Number: 24KBB818; 7) DYNJ51956B, UDI-DI: 10889942599394(each), 40889942599395(case), Lot Number: 24KBC171; 8) DYNJ41949B, UDI-DI: 10195327128937(each), 40195327128938(case), Lot Number: 24KBC614

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