Detailed Result for Z-1906-2010

CFRES ID: 91739
Device Name: N/A
Product RES Number: Z-1906-2010
Event Date Initiated: 2010-04-27
Event Date Posted: 2010-06-25
Event Date Created: N/A
Event Date Terminated: 2011-12-28
Recall Status: Terminated
Res Event Number: 55765
Product Code: OCK
K Numbers: N/A
PMA Numbers: ["P990002"]
Product Description: 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.
Code Info: REF Lot  71201 53500520 53500500 71201 53500599 53500598  71201DT 53500565 53500500 71201DT 53500600 53500598
Recalling Firm: Rochester Medical Corp
Firm FEI Number: N/A
Adress 1: 1 Rochester Medical Dr Nw
Adress 2: N/A
City: Stewartville
State: MN
Postal Code: 55976-1647
Additional Contact Info: 507-533-4203
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 Description: Packaging
Other Submission Description: N/A
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.
Product Quantity: 21,868 devices
Distribution Pattern: 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.
Medical Speciality Description: N/A
Regulation Number: N/A
Event Date Posted: 2010-06-25
Device Class: N/A
Open FDA: {"pma_number"=>["P960020", "P990002"], "device_name"=>"Transurethral Occlusion Insert, Urinary Incontinence-Control, Female", "medical_specialty_description"=>"Unknown", "regulation_number"=>"", "device_class"=>"3"}
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