Teleflex Recalls Soft Rubber Bladder Catheters Due to Missing Latex Warning
Teleflex Medical is recalling sterile soft rubber bladder catheters because the product labels failed to include a Natural Rubber Latex caution statement.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard is a labeling error (missing latex warning) rather than a direct contamination or structural defect, and no illnesses or injuries are reported in the source text.
Plain-English summary
Teleflex Medical is recalling specific lots of Rusch Soft Rubber (Nelaton and Nelaton Robinson) Bladder Catheters, Sterile. These catheters are indicated for the routine drainage of urine from the bladder and are not intended for indwelling use. The recall involves 194,503 units distributed nationwide in the United States and in various countries worldwide, including Austria, Belgium, Canada, Germany, and the United Kingdom.
The recall was initiated due to a misbranding issue. Although the product labeling identifies the catheters as "soft rubber," the required Natural Rubber Latex caution statement was not printed on the product label. This omission means that patients with a latex allergy may not be adequately warned of the potential allergen present in the device.
Healthcare facilities and distributors should stop using the affected catheters and contact Teleflex Medical for instructions on return or replacement. Patients who have used these catheters and have a known latex allergy should consult their healthcare provider if they experience any adverse reactions.
The recalled product
- Product
- Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Catheters
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 (20)
- Product Code #402100060
- Lot #13491 & 13501
- Product Code #402140120
- Lot #13371
- 13391 & 13511
- Product Code #401140140
- 13501
- 14091
- 14141
- 13271
- 13461
- 13481
- 14061
- 14081 & 14101
- Product Code #402140160
- Lot #13411
- 13291
- 13311
- 13301
- 13391 & 13491
Distribution
Distributed nationwide across the United States.
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