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Terminated

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" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.

FDA Recall Z-0004-2013 · Posted 2012-10-02

Recalling FirmCure Medical LLC
Recall StatusTerminated
Product CodeEZD
Date Initiated2012-09-19
Date Terminated2013-02-07
Product Quantity420cases (= 4,200 boxes)

Reason for Recall

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.

Firm 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 assignment of a return goods authorization. e) Cure Medical will replace any incorrect product along with processing costs for this situation to the dealer. If affected product was further distributed customers were asked to identify those customers who received them and notify them of the problem. For questions customers were instructed to call 1-800-570-1778.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072539CURE CATHETERCure Medical, LLC · 2007-09-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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