This is a follow-up alert to the November 30th FDA safety communication about plastic syringes manufactured in China. The FDA is evaluating potential device failures such as leaks, breakage, and other concerns, as these plastic syringes “may not provide consistent and adequate quality or performance”.
Hospitals should already be aware of this potential issue; this alert is to inform you that the scope of the issue may be broader than initially suspected. Depending on the FDA’s findings, a recall could disrupt availability of plastic syringes in the coming weeks.
There are currently no concerns regarding glass syringes, pre-filled syringes, or syringes used for oral and topical purposes.
FDA recommended actions for hospitals are:
- Check where your syringes are manufactured. This information is found on the packaging or contact your supplier.
- If possible, consider using plastic syringes not manufactured in China.
If your hospital uses plastic syringes manufactured in China, it will be prudent to assess availability of syringes manufactured outside of China. With limited immediate options, in the event of a recall, it is expected that demand could quickly exceed supply. Plan ahead, and if your hospital has experienced any issues with plastic syringes, you are encouraged to report these to the FDA.
Please contact Miga if you need any additional information or assistance locating an alternative supply of plastic syringes.