Recall Z-1974-2019— Teleflex Medical
Class III · Terminated
Class III FDA medical device recall by Teleflex Medical, initiated 2019-01-14, terminated 2022-12-13. FDA's recall record names no specific 510(k) clearance for this event. Product: RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device. Reason: The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling..
- Recalling firm
- Teleflex Medical
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-01-14
- Terminated
- 2022-12-13
- Firm location
- Morrisville, NC, United States
Product description
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Reason for recall
The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.