Nephrostomy balloon kits recalled after containing the wrong sized catheter
Olympus is recalling 60 Nephro-EZDilate nephrostomy balloon catheter kits because they contained a 4mm x 4cm urinary tract balloon instead of the correct 8mm x 15cm nephrostomy balloon.
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: Scored 3 under the risk-of-harm criterion: a kit supplying the wrong size balloon catheter for the procedure is a hazard, and no injuries are reported.
Plain-English summary
The Olympus Nephro-EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit, model BPCN0815K, is being recalled.
The device kits contained an incorrectly sized 4 mm x 4 cm urinary tract balloon catheter (BURS0404) instead of the correct 8 mm x 15 cm nephrostomy tract balloon catheter (BPCN0815). Olympus states all other components in the kits were correctly included and packaged.
The recall covers 60 units carrying UDI 00821925033016, from lot 25037006. The product was distributed in Alaska, California, Iowa, Kentucky, Washington and Wisconsin, and internationally to Canada and Germany. The FDA has classified the action as Class II.
A balloon of the wrong size cannot dilate the intended tract. The enforcement record reports no injuries. Facilities holding the affected lot should quarantine it and follow Olympus' instructions.
The recalled product
- Product
- Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: The Nephro-EZDilate nephrostomy balloon catheter is a reinforced catheter…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 60
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 (3)
- Model: BPCN0815K
- UDI: 00821925033016
- Lot Number: 25037006
Distribution
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