Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pediatric Recalled by Cure Medical LLC Due to Some of the intermediate boxes within lot 140417-3,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cure Medical LLC directly.
Affected Products
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. Intended to be used by pediatric males and females for the purpose of bladder drainage
Quantity: 192 cases = 1,920 boxes = 57,600 each
Why Was This Recalled?
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cure Medical LLC
Cure Medical LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report