FDA Device recall Z-0496-2015
Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F*…
- FDA Device
- Class II
- terminated
- Published 2014-12-10
On 2014-12-10 the FDA classified a Class II recall of Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F*… by Cure Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0496-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-11 |
| Published | 2014-12-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cure Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot Number: 140417-3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2015%22
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