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.
This recall is currently active, issued October 19, 2016. It was issued by Guangzhou Improve Medical Instruments Co., Ltd. No..
- Recall Initiated
- October 19, 2016
- Recall Number
- Z-2790-2018
- Quantity
- 700,000
- Firm Location
- Science City Guangzhou, China
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Distribution
Puerto Rico
Lot / Code Info
Serial Number 102030132 Lots #'s: 20150210 and 20150410
Root Cause
Nonconforming Material/Component
Action Taken
Several e-mails were sent between the manufacturer to the US distributor in 2016