Cook Inc. Recall: Micropuncture Check-Flo Performer Introducer Set, Individual product i
Cook Inc. Recall: Micropuncture Check-Flo Performer Introducer Set, Individual product i is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cook Inc.; Product: Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introd
| Recalling firm | Cook Inc. |
|---|---|
| Product | Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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, Czec |
| Recall initiated | 20170201 |
| Recall number | Z-1391-2017 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
Try RecallGuard →