Z-1913-2010

FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester...

Name: Z-1913-2010 FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester...
Creator: Rochester Medical Corp
Published: 2010-04-27
License: https://open.fda.gov/license/

Rochester Medical Corp. / initiated 2010-04-27 / Terminated / root cause: packaging

FDA source

Rochester Medical Corp began a recall of FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted Sizes Multi-Pack, REF 70200. Rochester Medical Corporation, One Rochester Medical drive... on 2010-04-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1913-2010
Status: Terminated
Initiated: 2010-04-27
Posted: 2010-06-25
Terminated: 2011-12-28
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.
Product code: OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
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
Root cause tag: packaging
FDA 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 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.
Product codes and lots: 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

Product code OCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)