FDA Medical Device Recalls (openFDA)
Rochester Medical Corp: FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
- Recall number
- Z-1906-2010
- Recalling firm
- Rochester Medical Corp
- Product
- FemSoft Insert, Female Urethral Insert, Size 1 Standard, 3.5 cm Length, REF 71201 or 71201DT, Sterile (R), Rx Only. Rochester Medical Corporation, One Rochester Medical drive, Stewartville, MN 55976 USA.
- 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
- 21,868 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 71201 53500520 53500500 71201 53500599 53500598 71201DT 53500565 53500500 71201DT 53500600 53500598
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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