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U.S. Department of Health and Human Services

Class 2 Device Recall SpeediCath , SpeediCath with Accessories

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 Class 2 Device Recall SpeediCath , SpeediCath with Accessoriessee related information
Date Initiated by FirmApril 21, 2011
Date PostedJune 03, 2011
Recall Status1 Terminated 3 on April 24, 2012
Recall NumberZ-2410-2011
Recall Event ID 58681
Product Classification Catheter, urethral - Product Code GBM
ProductSpeediCath , SpeediCath with Accessories Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark 284821 1400 SpeediCath, acc CH10 Male 284831 1400 SpeediCath, acc CH12 Male 284841 1400 SpeediCath, acc CH14 Male 284851 1400 SpeediCath, acc CH16 Male 284861 1400 SpeediCath, acc CH18 Male 284811 1400 SpeediCath, acc CH8 Male 285011 1400 SpeediCath,acc CH10 Female 285021 1400 SpeediCath,acc CH12 Female 285031 1400 SpeediCath,acc CH14 Female 285041 1400 SpeediCath,acc CH16 Female 284991 1400 SpeediCath,acc CH6 Female 285001 1400 SpeediCath,acc CH8 Female The SpeediCath catheter is indicated for use by patients with chronic urine retention and patients with post void a residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urin to drain. The insertion supplies provided are to be used to insert the catheter using sterile technique.
Code Information 2641603 2692541 2752163 2771698 2803598 2395370 2440555 2509063 2516364 2524050 2651814 2668369 2712685 2717532 2727614 2740196 2752164 2771659 2785552 2803602 2018979 2337367 2365131 2365132 2365134 2365135 2564957 2600245 2641600 2668412 2679492 2692543 2712686 2717531 2727613 2752165 2761468 2771696 2803595 2283082 2465091 2651905 2679493 2692545 2712687 2752166 2757289 2771701 2785553 2803599 2130238 2345466 2403178 2651870 2771700 2651868 2771695 2803600  2233842 2233842 2283075 2583200 2600244 2668374 2679497 2752168 2771692 2785551 2803601 2556881 2668363 2679495 2727615 2752169 2771694 2785548 2803597 2082467 2327518 2403253 2641601 2692542 2727612 2752170 2771697 2803596 2442703 2648503 2679494 2761467 2785554 2474786 2668366 2752167 2771702 1930978 2411690 2509038 2651872 2679496 2717533 2761247 2771691 2785550 
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact
612-302-4992
Manufacturer Reason
for Recall		Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i
FDA Determined
Cause 2		Incorrect or no expiration date
ActionColoplast Manufacturing US, LLC sent a Coloplast "Product Field Correction Notice" dated April 21, 2011. The letter was addressed to "Dear Valued Customer". The letter described the problem and the product involved in the recall. Customers were advised to provide the current inventory levels of the lots affected and the firm will be providing them with new iodine prep pads with sufficient shelf life. This product will include customer instructions, informing the customer to discard the original prep pads and use the new prep pads instead. If they prefer, they could themselves send the affected product back to Coloplast and they in return will attach new prep pads to the product for them. If they have further distributed the product, they advised consignees to contact their customers and to include the letter provided to them to inform them of the recall.
Quantity in Commerce126,347
DistributionNationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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