Recall Z-2790-2018— Guangzhou Improve Medical Instruments Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Guangzhou Improve Medical Instruments Co., Ltd., initiated 2016-10-19. It names one FDA 510(k) clearance: K123987. 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.. Reason: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip..
- Recalling firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2016-10-19
- Firm location
- Guangzhou, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Data sourced from openFDA. This site is unofficial and independent of the FDA.