Wellspect Recalls LoFric Origo Urethral Catheters Due to Tip Defect
Wellspect HealthCare is voluntarily recalling specific LoFric Origo urethral catheters due to 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 that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Wellspect HealthCare, a division of DENTSPLY IH AB, is voluntarily recalling certain LoFric Origo urethral catheters. The recall is due to a potential defect that may be present in the distal tip of the catheters.
The affected products are LoFric Origo, Tiemann, 16in, FR14 urinary catheters. The specific lot numbers involved in this recall are 447121, 447260, 449679, and 450503.
These catheters 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 in Australia, Brazil, Canada, the European Union, China, South Korea, Kuwait, New Zealand, Singapore, and the United Kingdom. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- LoFric Origo, Tiemann, 16in, FR14 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 (4)
- Lot #s: 447121
- 447260
- 449679
- 450503
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 Urinary 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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