Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized usi

FDA device recall Z-3174-2011 · posted 2011-09-09 · Terminated

Recall details

Recalling firm

Coloplast Manufacturing US, LLC

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

EXB

Quantity affected

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.

Date initiated

2011-07-27

Date posted

2011-09-09

Date terminated

2012-06-05

Location

Minneapolis, MN