Z-2985-2024 Class II Ongoing
FDA device recall Z-2985-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Apr 8, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Apr 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Medline Convenience kits, labeled as: 1) DYNJ39451D , Pack Number HOOD PACK ; 2) DYNJ59573A , Pack Number ICU RESPIRATORY BRONCH PACK ; 3) DYNJ80281A , Pack Number OSC BRONCH PACK
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 Pattern
Worldwide distribution.
Code Information
DYNJ59573A , Lot Number 23IBP764 ; DYNJ59573A , Lot Number 23JBM050 ; DYNJ59573A , Lot Number 23KBM610 ; DYNJ59573A , Lot Number 24ABC779 ; DYNJ39451D , Lot Number 22BDB647 ; DYNJ39451D , Lot Number 22CDA099 ; DYNJ39451D , Lot Number 22LDA195 ; DYNJ39451D , Lot Number 23DDB501 ; DYNJ39451D , Lot Number 23DDB666 ; DYNJ39451D , Lot Number 23EDA821 ; DYNJ80281A , Lot Number 23ADA194 ; DYNJ80281A , Lot Number 23DDA881 ; DYNJ80281A , Lot Number 23HDA513 ; DYNJ80281A , Lot Number 23JDC172 ; DYNJ80281A , Lot Number 23LDB860 ; DYNJ80281A , Lot Number 24ADC258 ; DYNJ80281A , Lot Number 24CDA973
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2985-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026