The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes. The alert was issued for Zhejiang Longde Pharmaceutical Co. and Shanghai Kindly Enterprise Development Group Co. for not meeting device quality system requirements.

The FDA recommends that users immediately transition away from using plastic syringes produced by those manufacturers, along with those made by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., unless absolutely necessary until users can transition to alternatives. The FDA continues to evaluate other Chinese-made plastic syringes and recommends not using them, if possible. 

Related News Articles

Headline
The Food and Drug Administration has identified a Class I recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus…
Headline
The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products. The agency said Abiomed found its Impella…
Headline
Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during…
Headline
The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device…