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Recall Observatory FDA recall evidence

Device product

Colpo-Pneumo Occluder, Part CPO-6

Z-0098-2019

September 04, 2018

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 80993
Status
Terminated
Classification
Class II
Quantity
32538
Official record key
device-enforcement:Z-0098-2019

Official wording

Reason: The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.

Code information: Lots 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 24 7609, 247610, & 248112

Distribution pattern: The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.