Reported Jul 24, 2019 · Terminated
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 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 CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
- Lot codes and dates
- GTIN14026704645708
- Lot/Batch Numbers
20161005201611202016112520170105201702102017030120170401201704022017050120170601201708012017090220170904201710012017110120171201201801012017080220170701
- Amount recalled
- 105426 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 is not likely to 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Teleflex Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.