Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark. Catalogue Number Des

FDA device recall Z-0820-2011 · posted 2010-12-27 · Terminated

Recall details

Recalling firm

Coloplast Manufacturing US, LLC

Reason for recall

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.

Action taken

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 Needles based on their home consignment inventory to be provided for use with all Saline Testicular Implants; Copies of customer letters to be provided with each replacement needle; Changes in all Saline Testicular orders, and Field personnel to administer the details of the correction and make the direct customer contacts. For questions, contact the Customer Service/Field Inventory Representative at 612-337-7859 or email: usbam@coloplast.com

Root cause

Labeling False and Misleading

Status

Terminated

Product code

FAF

Quantity affected

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 Austr

Date initiated

2010-04-30

Date posted

2010-12-27

Date terminated

2011-12-17

Location

Mankato, MN