Cook Medical Recalls Universa Soft Ureteral Stent Sets Due to Packaging Error
Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets because they were incorrectly placed in boxes labeled for the Firm version.
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 and involves a labeling/packaging error where the inner product label is correct, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Cook Inc. is recalling 20 units of Universa Soft Ureteral Stent Sets (5 FR 26 cm, Reference part Number: UFH-526). The recall is due to a packaging error where the soft stent sets were incorrectly placed in outer boxes labeled as Universa Firm Ureteral Stent Sets. The pouch label on the individual product reflects the correct packaged product.
The affected units were distributed internationally to Australia. The specific lot number for the recalled items is 13060084. These medical devices are used for temporary internal drainage from the ureteropelvic junction to the bladder.
Healthcare providers and patients should stop using the affected units and contact Cook Inc. for further instructions or a replacement.
The recalled product
- Product
- Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Urological
- Hazard
- Affected units
- 20
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 Number: 13060084
Distribution
Distribution scope not specified by the agency.
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