Institute of Good Manufacturing Practices India®

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Cardinal Health recalls procedure kits over plastic syringes made in China

Cardinal Health has recalled procedure kits containing plastic syringes from China's Jiangsu Shenli Medical Production, according to the Food and Drug Administration (FDA). The recall affects Cardinal Presource products, some of which included syringes sourced from Merit Medical Systems. Merit recalled its kits after discovering they contained Jiangsu Shenli syringes, prompting Cardinal's action.

Cardinal identified over 500 affected product catalog numbers in its recall notice and advised customers to remove and discard the Jiangsu Shenli syringes from the kits. These kits are used for procedures like angiographies and neurointerventional surgeries.

Jiangsu Shenli, under FDA scrutiny with an import alert and warning letter, supplied syringes to Merit without proper authorization, leading to the recall. Cardinal urges customers to quarantine and label affected packs to ensure safe removal of the syringes from Merit kits. The remaining components in these kits are deemed safe for use.

The recall follows an FDA warning letter regarding Cardinal's distribution of Jiangsu Shenli syringes not cleared for use in all sizes included in convenience kits.