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Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C ...
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catal...
Due to 11 volt Backup Battery failures.
Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 ...
Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection
Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103...
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical ...
Potential for overpressure alerts.
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: P...
CGMP Deviations; deficiencies observed during FDA inspection
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 ...
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical...
Potential for overpressure alerts.
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-00...
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomyc...
CGMP Deviations; deficiencies observed during FDA inspection
Harbinger Motors Inc. - Loose Steering Gear Mounting Bolts
Broken or loose steering gear bolts can cause a loss of steering control, increasing the risk of a crash.
Henna Profix Black, 60 Gramm
Gesundheitsschädliche Substanz, Sonstige Gründe
HarmonyAIR A-Series Surgical Lighting System
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Lengt...
Potential for overpressure alerts.
Update 1: Traditional Cheese Company recalls French Bries because of contaminati...
The presence of Listeria monocytogenes in the products listed above. Symptoms caused by Listeria monocytogenes can be similar to flu and include high temperature, muscle ache or pain, chills, feeling or being sick and diarrhoea. However, in rare cases, the infection can be more severe, causing serious complications, such as meningitis. Some people are more vulnerable to listeria infections, including those over 65 years of age, pregnant women and their unborn babies, babies less than one month old and people with weakened immune systems.