Z-2549-2018Class II
Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
Guangzhou Improve Medical Instruments Co., Ltd. / initiated 2017-09-22 / Open, Classified
Guangzhou Improve Medical Instruments Co., Ltd. began a recall of Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO on . FDA classified it as Class II and gives the reason as "Leaks complaints". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2549-2018
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- Product
- Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
- Product code
- FMI Needle, Hypodermic, Single Lumen
- Reason for recall
- Leaks complaints.
- FDA root cause
- Under Investigation by firm
- Action
- Several e-mails in early 2017 were sent to their only US consignee.
- Quantity in commerce
- 200,000
- Distribution
- Kansas
- Product codes and lots
- Serial Number 102030178 Lots #: 160809
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2549-2018 | Class II | Ongoing | Voluntary: Firm initiated |
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