BALT USA, LLC: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Descr

Hazard

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

Details from the source

Reason for recall: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. Distribution: US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. Quantity: 207 catheters Lot/code info: Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810) Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956

UPC codes

00840303711780, 00840303711797, 00840303711803, 00840303711810

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.