Product Wiki · Recalls · U.S. FDA — Device Enforcement

Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack… — recall Z-3003-2024

U.S. FDA — Device Enforcement · United States · 2024-04-08 · Class II

As described by U.S. FDA — Device Enforcement: Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3003-2024
Date of alert
2024-04-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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