Device product
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
Z-2790-2018
Product summary
- Event
- Event 80519
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 700,000
- Official record key
device-enforcement:Z-2790-2018
Official wording
Reason: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Code information: Serial Number 102030132 Lots #'s: 20150210 and 20150410
Distribution pattern: Puerto Rico
Derived failure modes
-
Unknown
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.