FDA Recall
Open, Classified
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.
Recall: Z-2790-2018
·
Initiated October 19, 2016
Recall
- Recall Number
- Z-2790-2018
- Event Number
- 80519
- Firm
- Guangzhou Improve Medical Instruments Co., Ltd. NO.
- FEI Number
- 3008449424
- Product Code
- FMI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- October 19, 2016
- Address
- 102 Kaiyuan Avenue, Science City Guangzhou, China
Description
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.
Reason
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Action
Several e-mails were sent between the manufacturer to the US distributor in 2016
Distribution
Puerto Rico
Quantity
700,000