Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Intr...

FDA Device Recall #Z-0601-2021 — Class I — November 24, 2020

Recall Summary

Recall Number Z-0601-2021
Classification Class I — Serious risk
Date Initiated November 24, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cook Inc.
Location Bloomington, IN
Product Type Devices
Quantity 1780

Product Description

Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Reason for Recall

There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage.

Distribution Pattern

US Nationwide Distribution including states of: AK, CT, IA, LA, MO, NH, OK, TN, WI, AL, DC, ID, MA, MS, NJ, OR, TX, WV, AR, DE, IL, MD, MT, NM, PA, UT, WY, AZ, FL, IN, ME, NC, NV, RI, VA, CA, GA, KS, MI, ND, NY, SC, VT, CO, HI, KY, MN, NE, OH, SD, WA and Global Distribution to: AU, SG, Austria, Belgium, Canary Islands, CN, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, KR, Latvia, Lithuania, MY, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, TW, TH, and United Arabs Emirates.

Lot / Code Information

Lot Numbers: 13143101, 13150445, 13159707, 13159715, 13166166, 13168195, 13186332, 13186337, 13214441, 13217127, 13221797, 13223835, 13229666, 13237660, 13246546, 13249446, 13262327, 13265329, 13291866, 13294513, 13307179, 13318024, 13332149, 13332159, 13337780, 13337796, 13346086, 13352434, 13352441, 13354252, 13366190, 13366197, 13382711, 13396125, 13398833, 13398835, 13413758, 13420106

Other Recalls from Cook Inc.

Recall # Classification Product Date
Z-0388-2022 Class II Flexor Check-Flo Introducer Ansel Modification ... Nov 12, 2021
Z-0387-2022 Class II Flexor Check-Flo Introducer Ansel Modificatio... Nov 12, 2021
Z-0414-2022 Class II Skinny Needle with Chiba Tip. RPN 090010, 09001... Oct 13, 2021
Z-0222-2022 Class II Transseptal Needle, Trocar. RPN TSNC-18-71.0, T... Oct 8, 2021
Z-0223-2022 Class II Transseptal Needle with Catheter. RPN TSN-17-75... Oct 8, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

More from Cook Inc. Recalls by Firm Recall Reasons Device Safety Stats