Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Reported: March 8, 2017 Initiated: February 1, 2017 #Z-1389-2017
Product Description
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
Reason for Recall
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 1,589
- Distribution
- Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Armenia, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Spain, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kenya, Kuwait, Lithuania, Mauritius, Netherlands, Norway, Oman, Poland, Reunion, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom VA/DOD: Yes
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.. Recalled by Cook Inc.. Units affected: 1,589.
Why was this product recalled? ▼
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1389-2017.
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