Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number)
Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1. 24FR(8124), 2. 28FR(8128), 3. 32FR(8132), 4. 36FR(8136);
Why it was recalled
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
1. Model Number(Size): 8124(24FR); UDI-DI: 00650862132243; Lot Number: ME244852; 2. Model Number(Size): 8128(28FR); UDI-DI: 00650862132281; Lot Number: ME244854, ME244855; 3. Model Number(Size): 8132(32FR); UDI-DI: 00650862132328; Lot Numbers: ME244565, ME244858, ME244859; 4. Model Number(Size): 8136(36FR); UDI-DI: 00650862132366; Lot Number: ME244861; — 2533
Record details
Atrium Medical Corporation — US Nationwide distribution.