Recall issued by FDA for certain craniotomy kits
The Food and Drug Administration has identified a Class I recall of certain lots of Medline Industries Craniotomy Kits containing recalled Codman Disposable Perforators 14mm due to the potential of serious injury or death. The recall was issued due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure. The recall involves correcting the devices and does not call for them to be removed from where they are used or sold.
Related News Articles
Headline
The Food and Drug Administration has identified a Class I recall of North American Rescue first aid kits containing TRUE METRIX Blood Glucose Monitoring…
Headline
The Food and Drug Administration has identified a Class I recall of reprocessed electrophysiology and ultrasound catheters by Medline Industries due…
Headline
The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of…
Headline
The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with…
Headline
The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy…
Headline
The Food and Drug Administration has identified a nationwide recall. Arrow International is recommending dialysis catheter kits containing Merit Medical 16F…