Recall Z-0496-2015 ยท EZD Catheter, Straight
Cure Medical LLC
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 pl
| Date | Dec 16, 2014 (initiated Nov 11, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Cure Medical sent Urgent: Medical Device Correction and Removal Notification, dated November 11, 2014, to customers. The letter identified the affected product and the reason for the recall. Customers were asked to immediately quarantine all cases of P10 catheters, with Lot Number 140417-3, and destroy any boxes that are labeled as P8, Lot 140410-3 and contact us for replacement products. Additionally, if any cases of P10, Lot 140417-3 products or boxes of P8 products, Lot Number 140410-3 were further distributed, those customers were to be identified and notified of the problem via the en |
| Quantity | 192 cases = 1,920 boxes = 57,600 each |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110653 | CURE CATHETER Cure Medical, LLC, Aug 1, 2011 |