Recall Z-0004-2013 ยท EZD Catheter, Straight
Cure Medical LLC
Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. 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. K072539 The Cure Catheter" dev
| Date | Oct 2, 2012 (initiated Sep 19, 2012) |
| Status | Terminated |
| Reason | The firm initiated the product recall because labeling on some of the intermediate boxes of catheters identify the contents to be M16C, a coud-tip catheters while the actual contents are M16Fr male, 16Fr, straight-tip catheters with the pouch and the case box labeled as M16Fr male, 16Fr, straight-tip catheters. |
| Root cause | Labeling mix-ups |
| Action | Cure Medical LLC sent an Urgent Medical Device Correction and Removal Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter instructed the customers to: a) Check their shelves for M16C with lot number 120425 and quarantine all affected product. b) Verify the contents (pouch label) are M16C and correspond with the intermediate box label. c) If all match, have the dealer sign and return a supplied verification record. d) If any mismatch is found, contact Cure Medical for |
| Quantity | 420cases (= 4,200 boxes) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072539 | CURE CATHETER Cure Medical, LLC, Sep 13, 2007 |