Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0597-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Product Classification:

Class I

Date Initiated: November 24, 2020

Date Posted: December 30, 2020

Recall Number: Z-0597-2021

Event ID: 86804

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.

Status: Terminated

Product Quantity: 1262

Code Information:

Lot Numbers: 13077814, 13089577, 13105054, 13140910, 13159710, 13162739, 13170661, 13186251, 13192084, 13194969, 13194972, 13200439, 13203160, 13203163, 13203166, 13214447, 13214449, 13217121, 13217122, 13219552, 13223826, 13223829, 13237651, 13276238, 13276245, 13286649, 13357239, 13366218, 13391145, NS13089580, NS13105058, NS13130292, NS13138931, NS13192091, NS13234809, NS13252367, NS13252368, NS13286655, NS13349016, NS13352450, NS13366219, NS13372482, NS13375232, NS13401834, NS13420125

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.

Voluntary or Mandated:

Voluntary: Firm initiated