BEUDAMED
    FDA Recall Terminated

    FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long.

    Recall: Z-1907-2010 · Initiated April 27, 2010

    Recall

    Recall Number
    Z-1907-2010
    Event Number
    55765
    Firm
    Rochester Medical Corp
    FEI Number
    2130787
    Product Code
    OCK
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    April 27, 2010
    Posted
    June 25, 2010
    Terminated
    December 28, 2011
    Address
    1 Rochester Medical Dr Nw, Stewartville, MN, 55976-1647

    Description

    FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA. The Multi-pack products contains 28 devices of the following: -8 of size 1 Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1 Long; -4 of size 2 Long; and -4 of size 3 Long.

    Reason

    Rochester Medical is voluntarily recalling specific lots of FemSoft urethral inserts manufactured and distributed in 2009 and 2010. Testing has revealed a small number of packages which contain a small void in the package seal, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for increased risk of urinary trac

    Action

    Consignees were contacted by telephone on 5/3/10 and if not reached, were sent a Rochester Medical "Urgent Medical Device Recall" letter on 5/6/10 dated April 26, 2010. The letter was addressed to Rochester Medical Corporation Customers. The letter described the problem and product involved; recommended consignees to record the quantity and lot numbers (s) on the enclosed postcard and return it to them; and to immediately destroy the product with the lots affected. In the case of distributors, the telephone call was followed by a letter sent/dated April 27, 2010 to each distributor. It advised distributors to isolate any remaining inventory with the specified lot numbers and to complete the disposition report. Letters included a customer letter for dissemination to their retail level customers. Retail customers were asked to segregate and destroy the affected products and record the action. The company will replace the destroyed product. The distributors started their contact to consignees on 4/28/10. Please contact Rochester Medical at 1-800-243-3315, or the firm's Customer Service Department at 1-507-533-9309 for additional information or for product return & replacement instructions.

    Distribution

    AL, AK, AZ, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WY, WI,. AUSTRIA, BANGLADESH, CANADA, CYPRUS, ETHIOPIA, FRANCE, GERMANY, GREECE, INDIA, JAPAN, KOREA, NETHERLANDS, P.R. CHINA, SAUDI ARABIA, SCOTLAND, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TURKEY, UAE, UNITED KINGDOM.

    Quantity

    1, 820 devices