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
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
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 22 Sep 2017 | Recall initiated by company | |
| 24 Apr 2019 | Classified by FDA | +579 days |
| 1 May 2019 | Published 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.
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.
More recalls from Guangzhou Improve Medical Instruments
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Improve Blood Collection Sets recalled by Guangzhou Improve Medical | Guangzhou Improve Medical Instruments | Other | PR |
| Device | CLASS II | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO recalled | Guangzhou Improve Medical Instruments | Packaging Defects | KS |
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