Class II

Medical Device Recall: Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT70

MEDLINE INDUSTRIES, LP - Northfield · April 8, 2024

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

Centurion procedure packs, containing Caina syringes, labeled as: 1) BREAST BIOPSY KIT, Pack Number DYNDH1512A; 2) CIRCUMCISION KIT, Pack Number CIT6535; 3) CIRCUMCISION KIT, Pack Number CIT7095; 4) CIRCUMCISION TRAY, Pack Number CIT6860A; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT6720; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 9) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

Distribution

Worldwide distribution.

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2780-2024

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.