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Recall Observatory FDA recall evidence

Device product

Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is 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. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

Z-1217-2019

September 22, 2017

Class II

Product summary

Firm
Guangzhou Improve Medical Instruments Co., Ltd.
Event
Event 80547
Status
Ongoing
Classification
Class II
Quantity
550,000
Official record key
device-enforcement:Z-1217-2019

Official wording

Reason: Complain due to the hub needle came out when the nurse draw the blood and removed the tube.

Code information: Serial # 102030178 / Lot # 160815

Distribution pattern: US Nationwide distribution in the state of Kansas.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Complain due to the hub needle came out when the nurse draw the blood and removed the tube.