On July 18, the FDA announced the issuance of an additional warning letter to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products. As a result, Jiangsu Shenli Medical Production Co. Ltd.’s entry on import alert 89-04 was expanded to prevent their enteral syringes from entering the United States.
A warning letter was also issued to Jiangsu Caina Medical Co., Ltd. for quality system violations.
The FDA recommendations have been updated to include that users should also immediately transition away from using enteral syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd., unless use of these syringes is absolutely necessary until the transition to enteral syringes manufactured by a different manufacturer can be completed.
The FDA says that it will continue its efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
Healthcare Purchasing News has been covering the warnings since March of this year.
