It was reported that the plunger of the feeding syringe was "very hard to push." to date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problems/issues.No sample was returned for evaluation.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on (b)(6) 2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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