Atrium Medical Corporation — Class II: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16F
Atrium Medical Corporation has initiated a Class II recall for specific lots of Getinge PVC Thoracic Catheters due to an out-of-specification (OOS) result during bacterial endotoxin testing.
This affects Atrium Medical Corporation, healthcare facilities utilizing these thoracic catheters, and professionals in quality control, sterile processing, and surgical inventory management.
An OOS result in endotoxin testing indicates a potential failure in the manufacturing or sterilization process, posing a risk of pyrogenic reactions in patients. This suggests a need for a root cause investigation into the specific lot's environmental controls or raw material handling to prevent recurrence.
QA and manufacturing teams should review endotoxin testing protocols and batch release criteria. Regulatory departments should monitor the status of this ongoing recall to ensure proper field action and reconciliation of affected lots.
Class II. Reason: An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.. Product: 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);. Firm: Atrium Medical Corporation (Merrimack NH United States). Status: Ongoing.
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