Recall Issued by FDA for Certain Craniotomy Kits

Correction Issued for Medline Craniotomy Kits Containing Codman Disposable Perforators - TechNation

This recall involves correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Craniotomy Kits containing Codman Disposable Perforator 14mm Unique

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 rem…