Recall Z-2410-2011 ยท GBM Catheter, Urethral
Coloplast Manufacturing US, LLC
SpeediCath , 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 CH
| Date | Jun 3, 2011 (initiated Apr 21, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Incorrect or no expiration date |
| Action | Coloplast 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 af |
| Quantity | 126,347 |
| Distribution | Nationwide 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.