FDA Recalls Safety Winged Blood Collection Sets Due to Needle Detachment
Guangzhou Improve Medical Instruments is recalling 550,000 Prevent G Safety Winged Blood Collection Sets because the hub needle detached during use.
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. The hazard involves a needle detaching during a medical procedure, which poses a risk of injury, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 550,000 units of the Prevent G Safety Winged Blood Collection Set Glide. The product is a single-use, sterile, winged needle bonded to flexible tubing with a luer adapter, used for the collection of venous blood. The manufacturer is Guangzhou Improve Medical Instruments Co., Ltd.
The recall was initiated due to a complaint that the hub needle came out when a nurse drew blood and removed the tube. The affected units are identified by Serial # 102030178 and Lot # 160815. The distribution pattern is listed as US Nationwide distribution in the state of Kansas.
Healthcare facilities and consumers should stop using the affected blood collection sets immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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)
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd.
- Hazard
- Affected units
- 550,000
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 # 102030178 / Lot # 160815
Distribution
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