Colpo-Pneumo Occluder, Part CPO-6
Reported: October 17, 2018 Initiated: September 4, 2018 #Z-0098-2019
Product Description
Colpo-Pneumo Occluder, Part CPO-6
Reason for Recall
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 32538
- Distribution
- 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.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
Colpo-Pneumo Occluder, Part CPO-6. Recalled by CooperSurgical, Inc.. Units affected: 32538.
Why was this product recalled? ▼
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2018. Severity: Moderate. Recall number: Z-0098-2019.
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