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U.S. Department of Health and Human Services

Class 2 Device Recall SenSura and Assura Postop Pouches

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  Class 2 Device Recall SenSura and Assura Postop Pouches see related information
Date Initiated by Firm July 27, 2011
Date Posted September 09, 2011
Recall Status1 Terminated 3 on June 05, 2012
Recall Number Z-3174-2011
Recall Event ID 59564
Product Classification Collector, ostomy - Product Code EXB
Product Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-Op ,ostomy bag with window, 70 mm , Sterilized using ethylene oxide; SenSura 19001 Drainable bag with soft tap 1 piece/Opaque with inspection windows, 10-76 mm Sterilized using ethylene oxide, Manufacturer: Colopast A/S 3050 Denmark.)

Coloplast Corp.-MN 06093, Country of origin: HU , No. 128100 1400 (Assura Post-Op 12810 pouches with window single use only, Sterile EO, 1/2" -3 7/8"/13-100mm) ; No. 128 180 1400 (Assura 12818 Post-Op, pouches without window, single use, Sterile EO, 1/2" -2 3/4"/13-70mm , Cut-to fit.; No. 128080 1400 ( Assura Post Op, 12808, pouches with window, single use, Sterile EO, 2 3/4 / 70 mm , Cut- to- fit) , Manufacturer: Colopast A/S 3050 Denmark.

These products are typically the first pouches applied in the OR following ostomy surgery. The one-piece drainable minimizes pressure on the abdomen, the soft drainable outlet accommodates the post-operative liquid output, and the inspection window allows a nurse to inspect and / or tend to the new stoma or wound. Thereafter, non-sterile bags are used for ostomy management both prior to and after the patient is discharged from the hospital.



Code Information Item code Lot. No 1280801400 2460849 1280801400 2467727 1280801400 2478730 1280801400 2487494 1280801400 2642633 1280801400 2694739 1280801400 2881701 1280801400 2899205 1281001400 2286634 1281001400 2442838 1281001400 2460851 1281001400 2467729 1281001400 2478732 1281001400 2494667 1281001400 2504331 1281001400 2517312 1281001400 2528041 1281001400 2542226 1281001400 2581246 1281001400 2597087 1281001400 2717298 1281001400 2740701 1281001400 2801394 1281001400 2818921 1281001400 2835494 1281001400 2858099 1281001400 2881703 1281001400 2899207 1281801400 2494669 1281801400 2528043 1281801400 2589985 1281801400 2771851 1900101400 2744870 1900101400 2897575 1900101400 2910204 1900101400 2913671 1901001400 2785864 1901001400 2928713 1901101400 2785865 1901101400 2928714 1901101400 2932901     
Recalling Firm/
Manufacturer
Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact
612-302-4992
Manufacturer Reason
for Recall
On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determined that all affected lots be recalled and quarantined. This affects lots manufactured and distributed from January 2010 until July 19, 2011.
FDA Determined
Cause 2
Process control
Action Coloplast sent a "RECALL OF STERILE SENSURA AND ASSURE POST-OP POUCHES" letter dated July 27, 2011 to all affected customers. An enclosed Field Safety Notice described the product, problem, and actions to be taken by the customers. Contact your Customer Service representative at 800-533-0464 for questions regarding this recall.
Quantity in Commerce 4020
Distribution Nationwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, GA, LA, MA, MD, MI, MN, MO, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX, VA, WA, and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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