Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues
Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 text explicitly states the labeling issue is not likely to 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 CARE Premium Drain bags, 2000ml, REF 390000, which are urine collection devices. The recall was initiated because the device labels are not UDI (Unique Device Identification) compliant. The missing UDI compliance information on the labeling is not likely to affect the function or performance of the device itself, and other label information and warnings are unaffected by this labeling issue.
The affected units were distributed worldwide, including the United States (nationwide) and Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. The recall covers 105,426 units. Specific lot numbers are listed in the agency's structured data, including 20161005, 20161120, and 20170105, among others.
Consumers and healthcare facilities should check their inventory for these specific drain bags and lot numbers. Since the issue is limited to labeling compliance and does not affect the device's performance or safety warnings, users should follow standard medical device handling procedures while awaiting further instructions from the manufacturer or regulatory agencies.
The recalled product
- Product
- RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 105,426
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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