Z-3011-2024 Class II Ongoing
FDA device recall Z-3011-2024 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) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516BH; 3) DIALYSIS PACK , Pack Number DYNJ36932A ; 4) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 5) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 6) NO CATH DIALYSIS INSERTN TRAY , Pack Number PICCNC0028
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
DYNDA2516B , Lot Number 23IBE112 ; DYNDA2516B , Lot Number 23JBH284 ; DYNDA2516B , Lot Number 23KBE900 ; DYNDA2516B , Lot Number 23LBO850 ; DYNDA2516BH, Lot Number 23IBE112 ; DYNDA2516BH, Lot Number 23JBH284 ; DYNDA2516BH, Lot Number 23KBE900 ; DYNDA2516BH, Lot Number 23LBO850 ; DYNJ36932A , Lot Number 23FBK320 ; DYNJ36932A , Lot Number 23GBU834 ; DYNJ36932A , Lot Number 23HBG572 ; DYNJ36932A , Lot Number 23LBL499 ; DYNJ58502C , Lot Number 21IMD970 ; DYNJ58502C , Lot Number 21KMA999 ; DYNJ910121 , Lot Number 24CDB254 ; PICCNC0028 , Lot Number 23KBL354
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3011-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026