Z-2630-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,679,067 units in total
Product Description
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ910121 ; 5) 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 ; 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