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U.S. Department of Health and Human Services

Class 2 Device Recall FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes MultiPack.

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  Class 2 Device Recall FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes MultiPack. see related information
Date Initiated by Firm April 27, 2010
Date Posted June 25, 2010
Recall Status1 Terminated 3 on December 28, 2011
Recall Number Z-1913-2010
Recall Event ID 55765
PMA Number P990002 
Product Classification Transurethral occlusion insert, urinal incontinence-control, female. - Product Code OCK
Product 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 FSSTDSUP product is a Clinician Supply Pack that is provided directly to
clinics. The Clinician Supply Pack is a package containing 2 multi-pack
boxes of product. The corresponding retail box label for this product
(FSSTDSUP) is the REF 70200. 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.
Code Information REF Lot Pouch  FSSTDSUP 53500538 53500500  FSSTDSUP 53500562 53500515  53500516  53500517  53500518  53500519  FSSTDSUP 53500607 53500598  FSSTDSUP 53500608 53500601  FSSTDSUP 53600629 53500604  53500586  53500587  53500588  
Recalling Firm/
Manufacturer		 Rochester Medical Corp
1 Rochester Medical Dr Nw
Stewartville MN 55976-1647
For Additional Information Contact
507-533-4203
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Packaging
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.
Quantity in Commerce 15,400 devices
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.
Total Product Life Cycle TPLC 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.
PMA Database PMAs with Product Code = OCK and Original Applicant = ROCHESTER MEDICAL CORP.
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