RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Reported: July 24, 2019 Initiated: January 14, 2019 #Z-1975-2019
Product Description
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Reason for Recall
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 76725 US eaches
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device. Recalled by Teleflex Medical. Units affected: 76725 US eaches.
Why was this product recalled? ▼
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Low. Recall number: Z-1975-2019.
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