Atrium Medical Corporation: 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);

Is my product affected?

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);

• UPC 00650862132243
• UPC 00650862132281
• UPC 00650862132328
• UPC 00650862132366

Check against the official notice below — it lists the full affected range.

Hazard

An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.

Details from the source

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: 2533 Lot/code info: 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;

Source

Official record: FDA (Device enforcement) ↗

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

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