FDA issues import alert, additional recommendations against using plastic syringes made in ChinaÂ
The Food and Drug Administration yesterday announced an 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.