CLASS II ONGOING Device recall · Reported 1 May 2019 · FDA Enforcement Report

Prevent G Safety Winged Blood Collection Set Glide recalled

Guangzhou Improve Medical Instruments is recalling Prevent G Safety Winged Blood Collection Set Glide, distributed nationwide in the US. The recall was initiated on 22 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial # 102030178 / Lot # 160815
Quantity recalled550,000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1217-2019
FDA event ID
80547
Recalling firm
Guangzhou Improve Medical Instruments, Guangzhou, N/A
Classification
Class II
Status
Ongoing
Recall initiated
22 Sep 2017
FDA classified
24 Apr 2019
Reported
1 May 2019
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Other Reasons

Timeline

22 Sep 2017Recall initiated by company
24 Apr 2019Classified by FDA+579 days
1 May 2019Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution in the state of Kansas.

Nationwide Kansas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Serial # 102030178 / Lot # 160815

Where was it sold?

US Nationwide distribution in the state of Kansas.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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