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.
Recall
- Recall Number
- Z-3174-2011
- Event Number
- 59564
- Firm
- Coloplast Manufacturing US, LLC
- FEI Number
- 2125050
- Product Code
- EXB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 27, 2011
- Posted
- September 9, 2011
- Terminated
- June 5, 2012
- Address
- 1601 W River Rd, Minneapolis, MN, 55411-3431
Description
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.
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.
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.
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.
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