Micropuncture Check-Flo Performer Introducer Set — Class II medical device recall Z-1391-2017

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

Recall number	`Z-1391-2017`
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	778

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.

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-1391-2017. 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.