Teleflex Medical recalls RUSCH 2000ml urinary drainage bags with non-compliant UDI labels. The missing UDI information does not affect device function but may cause regulatory issues.
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.
Teleflex Medical is recalling RUSCH 2000ml urinary drainage bags due to missing UDI (Unique Device Identification) labels. This labeling issue does not affect the bag's function but could cause regulatory problems with medical device tracking.
The device labels lack required UDI compliance information, which is necessary for medical device tracking. However, this labeling issue does not affect the bag's function or safety during use. The missing information could cause regulatory problems but not immediate harm to patients.
Patients using the RUSCH 2000ml urinary drainage bags with the specified lot numbers are affected. Healthcare providers using these bags for medical procedures may also be impacted.
Check for the RUSCH 2000ml urinary drainage bags with lot numbers from 20161005 to 20171101. The product has a GTIN of 14026704645715.
Verify if the label includes the required UDI information as specified in the recall notice.
No, the missing UDI information does not affect the device's function or safety during use.
The recall does not require immediate action; check the label for UDI compliance and contact Teleflex Medical for further guidance.
Yes, the affected lot numbers range from 20161005 to 20171101.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1975-2019 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1975-2019 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.
