Reported Jul 24, 2019 · Terminated
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Teleflex Medical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
- Lot codes and dates
- GTIN14026704645715
- Lot/Batch Numbers
201610052016112020161125201701052017021020170401201704022017050120170801201709012017090220170903201709042017110120170701
- Amount recalled
- 76725 US eaches
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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