Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
Check against the official notice below — it lists the full affected range.
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Reason for recall: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. Distribution: US Nationwide distribution. Quantity: 3618 Lot/code info: 1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.