Flexor Radial Access Set — Class II medical device recall Z-1390-2017
Terminated recall by Cook Inc., reported 2017-03-08, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an i
| Recall number | Z-1390-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-02-01 |
| Classified | 2017-03-02 |
| Reported by FDA | 2017-03-08 |
| Terminated | 2018-09-28 |
| Distributed | 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 |
| Countries outside the US | AE, AT, BE, BG, CA, CH, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HU, IE, IT, KE, KW, LT, NL, NO, OM, PL, RO, SA, SE, SI, SK, TR, ZA |
| Quantity | 41,975 |
Product
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1390-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.