The Recall Desk
HighFDA (Devices)·Z-2549-2018·Announced 2018-08-01

FDA Recalls Prevent G Safety Winged Blood Collection Sets Due to Leaks

Guangzhou Improve Medical Instruments Co., Ltd. is recalling 200,000 Prevent G Safety Winged Blood Collection Sets in Kansas due to leak complaints.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II due to leak complaints in a medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 200,000 units of the Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO. The recall was initiated voluntarily by the manufacturer, Guangzhou Improve Medical Instruments Co., Ltd., on September 22, 2017. The product is identified by Serial Number 102030178 and Lot Number 160809.

The reason for the recall is complaints regarding leaks in the blood collection sets. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The affected products were distributed in Kansas. Healthcare facilities and consumers who have this specific product should stop using it and contact the manufacturer or their supplier for instructions on return or replacement.

The recalled product

Product
Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
Hazard
Affected units
200,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Number 102030178 Lots #: 160809

Distribution

Distributed in 1 state:

Same manufacturer · Guangzhou Improve Medical Instruments Co., Ltd.

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