Recall Z-3174-2011 ยท EXB Collector, Ostomy
Coloplast Manufacturing US, LLC
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.) Colo
| Date | Sep 9, 2011 (initiated Jul 27, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.