Devices

Device Recall Rectal Catheters;

Model / Serial
Batch Numbers: 13DE17 13EE22 13FE24 13FE26 13GE28 13GE29 13GE31 13KE47 13LE49 14AE03 14AE04 14FE25 14GE27 14HE32 14HE33 14HE35 14IE37 14IE38 14LE49 15AE05 15BE08 15CE13 15DE15 15DE16 15DE17 15DE18 15FE23 15FE25 15FE26 15GE27 15GE28 15GE29 15GE30 15HE32
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Rectal Catheters; || Product Code Equivalent Code || 580114 580114 || Product Usage: || Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.
Manufacturer
Teleflex Medical Europe Ltd
1 Event
- Recall of Device Recall Rectal Catheters;

Manufacturer

Teleflex Medical Europe Ltd

Manufacturer Address
Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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