Z-2632-2024 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) NEURO ANGIO PACK, Part Number DYNDA1431A; 2) CVC INSERT BUNDLE 16CM, Part Number ECVC3260; 3) CENTRAL LINE INSERTION KIT, Part Number ECVC7440; 4) CENTRAL LINE INSERTION KIT, Part Number ECVC7445; 5) CENTRAL LINE INSERTION KIT W/20CM CATH, Part Number ECVC7445A; 6) VANTEX 7FR 3L 20CM CVC BUNDLE US, Part Number ECVC8045; 7) CVC DOUBLE LUMEN 16CM, Part Number ECVC8105
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
DYNDA1431A, Lot Number 2019021190; ECVC3260, Lot Number 2019091850; ECVC3260, Lot Number 2019120950; ECVC7440, Lot Number 2021071950; ECVC7440, Lot Number 2021092150; ECVC7445, Lot Number 2021052850; ECVC7445, Lot Number 2021062250; ECVC7445A, Lot Number 2022012850; ECVC7445A, Lot Number 2023010390; ECVC8045, Lot Number 2023031590; ECVC8105, Lot Number 2023112190