Cure Medical LLC Recall: Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch
Cure Medical LLC Recall: Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cure Medical LLC; Product: Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC
| Recalling firm | Cure Medical LLC |
|---|---|
| Product | 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 |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution |
| Recall initiated | 20141111 |
| Recall number | Z-0496-2015 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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