FDA recall Z-2746-2024

Product

Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A; 2) CIRCUMCISION TRAY, Pack Number CIT7210; 3) CIRCUMCISION TRAY, Pack Number DYNDA2271; 4) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 5) UCLA - BREAST BIOPSY KITDYNDH1512A

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.

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2024