🏥 Medical Devices Class I - Dangerous
Product lacks premarket clearance.
Sunstar Americas
6 recalls • • Categories: Other Medical Devices, Infusion Pumps, Prescription Drugs
🏥 Medical Devices Class I - Dangerous
Products may be contaminated with micro-organisms Burkholderia cepacia and/or Burkholderia contaminans.
🏥 Medical Devices Class I - Dangerous
Product may be contaminated with Burkholderia contaminans.
The product may be contaminated with Burkholderia cepacia
💊 Drugs Class I - Dangerous
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
💊 Drugs Class I - Dangerous
Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.