Teleflex Medical recalls RUSCH CARE Premium Drain bags with missing UDI compliance labels. The labels do not affect device function but may cause issues with medical tracking.
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.
Teleflex Medical is recalling RUSCH CARE Premium Drain bags that lack required UDI (Unique Device Identification) labels. This issue does not affect the bag's function but could impact medical tracking and compliance.
The drain bags lack required UDI labels, which are necessary for medical device tracking. This does not cause device failure or injury but may lead to compliance issues with medical regulations.
Patients using urinary drainage bags and healthcare providers who manage these devices. Those most at risk are facilities that rely on accurate medical device tracking.
Check for the RUSCH CARE Premium Drain bag model with 2000ml capacity and reference number 390000. The lot/batch numbers range from 20161005 to 20180101 as listed in the recall notice.
Verify the presence of UDI compliance labels on the drain bag. If missing, the product is part of the recall.
No, the missing UDI labels do not affect the device's function or cause injury.
Check the product name, model (RUSCH CARE Premium Drain bag, 2000ml, REF 390000), and lot/batch numbers listed in the recall notice.
The recall does not require returning the product; checking for UDI labels is sufficient.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1974-2019 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1974-2019 from Teleflex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
