The Class I recall affects the Roadrunner Uniglide Hydrophilic Wire Guide, which is used in peripheral vascular procedures.
The catheter polymer degradation has resulted in 30 MDRs to date.
Failure to inform the agency about a pending correction or removal makes you an easy target.
FDA recently ordered a manufacturer of automated endoscope reprocessors to recall product following a consent decree from 2007.
If an establishment is executing corrections and removals and failing to notify FDA, then rest assured, a warning letter is in your establishment’s future; and no crystal ball is required to see into the future.