Class IIOngoingZ-0910-2025
Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1 ) ANEURYSM PACK
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Cardinal Health 200, L…ILJan 22, 2025
Cardiovascular Procedure Kit recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–52 of 52 recalls
Class IOngoingZ-0765-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Fluid Delivery Set with Drip Chamber: 1) MTO
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
MEDLINE INDUSTRIES, LP…ILJan 22, 2025
Class IIOngoingZ-0778-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
MEDLINE INDUSTRIES, LP…ILJan 8, 2025
Class IIOngoingZ-0718-2025
MEDLINE INDUSTRIES, LP - Northfield recalls FESS-MB PACK-LF Convenience kit
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and St…
MEDLINE INDUSTRIES, LP…ILJan 1, 2025