Recall Z-0820-2011 ยท FAF Prosthesis, Testicular
Coloplast Manufacturing US, LLC
Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Description Part Number 450-1323 Extra Small 520600 450-1325 Small 520610 450-1327 Medium 520630 450-1329 Large 520650 The Coloplast Saline-Filled Testicular Prosthesis is intended for use
| Date | Dec 27, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | On April 22, 2010, a decision was made by Coloplast to conduct a field correction based on a report that the Saline Filled Testicular Prosthesis is considered mislabeled. This is solely due to a difference in expiration dates between the Terumo Butterfly Needle included in the kit and the testicular implant. The needle has a 3yr expiration date & the Saline Testicular has a 5yr expiration date. |
| Root cause | Labeling False and Misleading |
| Action | The recall will extend to field personnel who have control of all SFTP Systems. The product is ordered by the customer (physician and/or hospital) directly from a field sales representative who ships the device to them or drops it off in person. Coloplast sent all Field Personnel an email on April 30, 2010, with a copy of a letter dated April 30, 2010 and a follow-up letter dated May 1, 2010. The letters described the problem and the product involved in the recall. The letters included a list of Corrections Required. This included the field personnel receiving a stock of sterile Butterfly N |
| Quantity | 1018 |
| Distribution | Worldwide distribution: USA including states of AL, AK, AZ, AR, CO, CT, CA, FL, GA, HI, IL, IN, IA, LA, MD, MA, MI,MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT and WA; and countries of Australia, Canada, Hong Kong and Latin America (Chile, Columbia, Ecuador and Venezuela). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.