Wellspect Recalls LoFric Origo Urinary Catheters Due to Tip Defect
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urinary catheters because of a potential defect in the distal tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential defect where injury has not yet been reported, fitting the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Wellspect HealthCare, a division of DENTSPLY IH AB, is voluntarily recalling certain LoFric Origo urethral catheters. The recall involves Nelaton, 16-inch, FR10 catheters from Lot # 447123.
The recall is being conducted due to a potential defect which may be present in the catheter's distal tip. The source text does not specify the exact nature of the defect or report any injuries or illnesses associated with the product.
These products were distributed in the United States (AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, VA) and internationally (Australia, Brazil, Canada, European Union, China, South Korea, Kuwait, New Zealand, Singapore, United Kingdom). Consumers should check their inventory for this specific lot number and contact the manufacturer for further instructions.
The recalled product
- Product
- LoFric Origo, Nelaton, 16in, FR10 urinary catheters
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 447123
Distribution
Part of a larger recall action
This product is one of 3 recalled by Wellspect HealthCare (Division of DENTSPLY IH AB) 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Wellspect HealthCare (Division of DENTSPLY IH AB)
See all →- HighWellspect Recalls LoFric Origo Urethral Catheters Due to Tip Defect
FDA (Devices) · 2020-07-29
- HighWellspect Recalls LoFric Origo Urinary Catheters Due to Tip Defect
FDA (Devices) · 2020-07-29
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