RUSCH Urinary Drainage bag recall: Labeling Error
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Why was RUSCH Urinary Drainage bag 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.
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: 14026704645715 Lot/Batch Numbers: 20161005 20161120 20161125 20170105 20170210 20170401 20170402 20170501 20170801 20170901 20170902 20170903 20170904 20171101 20170701
- Product
- RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
- Recalling firm
- Teleflex Medical
- Quantity
- 76725 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)