Recall Z-1906-2010 ยท OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
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.
| Date | Jun 25, 2010 (initiated Apr 27, 2010) |
| Status | Terminated |
| 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 a |
| 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, SCOTLA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.