RUSCH CARE Premium Drain bag recall: Labeling Error
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Why was RUSCH CARE Premium Drain bag recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 14026704645708 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170301 20170401 20170402 20170501 20170601 20170801 20170902 20170904 20171001 20171101 20171201 20180101 20170802 20170701
- Product
- RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
- Recalling firm
- Teleflex Medical
- Quantity
- 105426 US eaches
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
- Recall date
- July 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)