Loading...
Loading...
All product recalls affecting Kentucky.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Kentucky in the distribution area.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Medix Specialty Vehicles, Inc. (Medix) is recalling certain Phoenix Quick Liner Wheel Covers installed, with the clip-on feature, on Medix Ford Type-III ambulances. The wheel covers may detach during transit.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.