Class II

Medical Device Recall: Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pac

MEDLINE INDUSTRIES, LP - Northfield · February 11, 2025

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Product Description

Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pack Number DYNJ60669G; 5) FACE LIFT PACK, Pack Number DYNJ64670B; 6) FREE FLAP A PACK, Pack Number DYNJ40647G; 7) IPMC BREAST PACK-LF, Pack Number DYNJ0665560D; 8) OCULAR PLASTICS PACK, Pack Number DYNJ40356A; 9) OCULOPLASTY PACK-LF, Pack Number DYNJ0252232U; 10) PACK MASTECTOMY COMBO CHRG, Pack Number DYNJ60232A; 11) PLASTIC GENERAL SURGERY - OSC, Pack Number DYNJ43576A; 12) PLASTIC PACK, Pack Number DYNJ00264L; 13) PLASTIC PACK, Pack Number DYNJ49742B; 14) PLASTIC PK II, Pack Number DYNJ14039B; 15) PLASTIC-GENERAL SURGERY PACK, Pack Number DYNJ09866U; 16) PLASTICS FACIAL PACK ST MARY, Pack Number DYNJ45861B; 17) PLASTICS PACK, Pack Number DYNJ68288A

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

1228 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1462-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MEDLINE INDUSTRIES, LP - Northfield Medical Device Recall: Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREAST -LF, Pack Number DYNJCEN04C; 4) DIEP PACK, Pac | SafeCheck