The Recall Desk
SevereFDA (Devices)·Z-0596-2021·Announced 2020-12-30

Flexor Check-Flo Introducer sheath separation recall due to potential life-threatening complications

The FDA is recalling the Flexor Check-Flo Introducer because its sheath may separate at the proximal bond site, potentially causing serious complications such as embolization, vessel injury, 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 classified as FDA Class I, which per the severity rubric requires a minimum severity score of 4 regardless of reported illnesses. Although no deaths or injuries are reported in the source text, the FDA Class I designation mandates at least a 'Severe' rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is issuing Recall Z-0596-2021 for the Flexor Check-Flo Introducer (RPN KCFW-5.0-35-70-RB-HFANL0-HC). The recall addresses an increased likelihood of the introducer sheath separating at the proximal bond site during use. If separation occurs, it could result in life-threatening adverse events.

Potential adverse events associated with this issue include increased procedural time, the need for intervention to retrieve a separated segment, embolization that could occlude blood flow to a vital organ, vessel injury, and hemorrhage. These risks stem from the mechanical failure of the sheath design at the proximal bond location.

Consumers and healthcare providers should consult their physician or the manufacturer regarding the safety of continuing use. Until further information is available, patients should avoid using the recalled introducer until the issue is resolved or the device is replaced through proper channels.

The recalled product

Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 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 — Guide Sheath
Hazard
Affected units
2,807

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: 13089576
  • 13105053
  • 13130281
  • 13130282
  • 13135871
  • 13159711
  • 13159712
  • 13162740
  • 13166130
  • 13170660
  • 13175442
  • 13175443
  • 13186252
  • 13189278
  • 13192082
  • 13192083
  • 13192085
  • 13192086
  • 13192087
  • 13194970

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 · sheath separation

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