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Male, 16Fr, Straight-tip Intermittent Urinary Catheters… recallZ-0004-2013 · Cure Medical LLC · initiated Sep 19, 2012

Class II Terminated All recalls posted in October 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cure Medical LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0004-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 19, 2012
Posted by the FDA
Oct 2, 2012
Recalling firm
Cure Medical LLC
Quantity
420cases (= 4,200 boxes)
Product code
EZD
FDA submissions
K072539
Distribution
Nationwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

Total affected product: M16, Lot 120425: 420 cases = 4,200 boxes = 126,000 each. 2017.03 is shown on the product labeling as the expiry date for the product, 4 years and 11 months from the date of packaging. The product, M16, is identified with the following UPC Codes for the individual pouches, intermediate boxes and case labels:  ¿ Pouch Label UPC (M16) = *+M405M16 ¿ Box Label UPC (M16) = *+M405M163I* " Case Label UPC (M16) = *+M405M165K*   Explanation of Lot Number: The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility.   At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order The lot number represents a planned packaging date of a set of work orders for various products, in the format YYMMDD at the contract manufacturers facility.   At the order planning stage, the packaging date is estimated (based on production cycle time and pre-printed box delivery) and assigned to each work order scheduled for packaging on this estimated date.  Therefore, one lot number may be assigned to multiple catalog numbers. The lot number 120425 was assigned to both M16 and M16C products by the scheduling department  Actual packaging of the M16 occurred from 23 May 2012 through 25 May 2012.  Actual packaging of the M16C occurred from 19 May through 21 May 2012.

Other devices under the same FDA submission

14 devices cleared under K072539 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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