Wellspect Recalls LoFric Origo Urinary Catheters Due to Tip Defect
Wellspect HealthCare is voluntarily recalling LoFric Origo urinary 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 'High' severity criteria 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 specific lots of LoFric Origo urethral catheters. The recall is being conducted because of a potential defect that may be present in the distal tip of the catheters.
The affected product is the LoFric Origo, Tiemann, 16in, FR12 urinary catheter, specifically Lot # 450422. These products were distributed in the United States (including states such as AL, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NH, NJ, OH, PA, RI, SC, TX, and 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 the specific lot number listed above. If the product matches the recalled lot, it should be removed from use and returned to the supplier or manufacturer according to their instructions.
The recalled product
- Product
- LoFric Origo, Tiemann, 16in, FR12 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 # 450422
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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