FDA updates guidance on two product recalls

12/2/2010 | MedPage Today (free registration)

The FDA has released new guidance involving two Class I product recalls. In the first guidance, the FDA said the recall of addEASE Binary Connector, made by B. Braun, was caused by stopper fragments that can be released by the device and enter a patient's body, and that distribution and usage of the product should be halted. The second guidance updated the recall of infusion pumps from Baxter Healthcare to a Class I designation.

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