Rochester Medical Corp: 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.

Recall number

Z-1913-2010

Recalling firm

Rochester Medical Corp

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.

Status

Terminated

Initiated

2010-04-27

Posted

2010-06-25

Terminated

2011-12-28

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

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

["P990002"]

Product code

OCK

Firm FEI

2130787

Firm city

Stewartville

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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