Z-0496-2015 Class II Terminated
FDA device recall Z-0496-2015 was initiated by Cure Medical LLC on November 11, 2014 and is designated Class II. 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 f… The recall status is terminated (terminated April 10, 2015). Affected quantity: 192 cases = 1,920 boxes = 57,600 each.
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2014
- Initiation Date
- November 11, 2014
- Termination Date
- April 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 cases = 1,920 boxes = 57,600 each
Product Description
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.
Distribution Pattern
Nationwide Distribution
Code Information
Lot Number: 140417-3