device · product 1 of 1
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.
- Recall number
- Z-0004-2013
- Initiated
- September 19, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Cure Medical LLC
- Quantity
- 420cases (= 4,200 boxes)
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Labeling mix-ups
Inspect official wording and provenance
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.
Code information
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.
Distribution pattern
Nationwide Distribution