The Recall Desk
SevereFDA (Devices)·Z-0593-2021·Announced 2020-12-30

Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk

Cook Inc. is recalling 458 Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the hazard involves life-threatening adverse events such as embolization and hemorrhage, fitting the criteria for Severe.

Plain-English summary

Cook Inc. has initiated a recall of the Flexor Check-Flo Introducer (Order Number G56219). The product is a guiding sheath intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. A total of 458 units are affected.

The recall addresses an increased likelihood of the introducer sheath separating at the proximal bond site during use. If this separation occurs, it could result in life-threatening adverse events. Potential consequences include increased procedural time, the need for intervention to retrieve a separated segment, embolization that occludes blood flow to a vital organ, vessel injury, and hemorrhage.

The affected units have lot numbers 13059453, 13059454, 13059455, 13059463, 13126438, 13197461, 13197463, 13207360, 13207367, 13234807, 13279094, 13346108, 13279103X, NS13059462, NS13260029, NS13304443, NS13312714, NS13346096, NS13352471, NS13372477, NS13410219, and NS13426314. Distribution includes US Nationwide (including states 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 countries including 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.

Consumers and healthcare providers should check lot numbers against the list above. If affected units are in possession, they should be returned or handled according to FDA guidelines for medical device recalls.

The recalled product

Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Manufacturer
Cook Inc.
Category
Medical Device — Introducer Sheath
Hazard
Affected units
458

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: 13059453
  • 13059454
  • 13059455
  • 13059463
  • 13126438
  • 13197461
  • 13197463
  • 13207360
  • 13207367
  • 13234807
  • 13279094
  • 13346108
  • 13279103X
  • NS13059462
  • NS13260029
  • NS13304443
  • NS13312714
  • NS13346096
  • NS13352471
  • NS13372477

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 21 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · device separation

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