Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues
Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source explicitly states that the labeling error does not affect the device's function or performance, fitting the criteria for a Low severity score (documentation/packaging issues).
Plain-English summary
Teleflex Medical is recalling RUSCH Urinary Drainage bags, 2000ml, REF 390060, due to non-compliant labeling. The recall involves 76,725 units distributed nationwide in the United States and in Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. The affected lot numbers are 20161005, 20161120, 20161125, 20170105, 20170210, 20170401, 20170402, 20170501, 20170801, 20170901, 20170902, 20170903, 20170904, 20171101, and 20170701.
The recall was initiated because the device labels are not UDI (Unique Device Identification) compliant. According to the source text, the missing UDI compliance information on the labeling would not affect the function or performance of the device itself. Other label information and warnings are unaffected by this labeling issue.
Consumers and healthcare providers should check their inventory for the specific reference number and lot numbers listed above. Since the issue is limited to labeling compliance and does not impact the device's performance, no specific safety action regarding device usage is mandated by the source text, but users should be aware of the recall status.
The recalled product
- Product
- RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Urology
- Hazard
- Affected units
- 76,725
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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