FDA (Devices) recall action 86804

Cook Inc. recalled 21 products on 2020-12-30

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2020-12-30
Critical: 1
Units: 48,667

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–21 of 21

SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Product
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.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk
Cook Inc. is recalling 902 Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 228 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··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.
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.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
CriticalFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducer Sheaths Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducer sheaths because the proximal bond site may separate, potentially causing life-threatening adverse events such as embolization or hemorrhage.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling 383 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events during use.
Product
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
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.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Sheath Separation Risk
Cook Inc. is recalling 631 Flexor Check-Flo Introducers because the sheath may separate at the proximal bond site, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Tuohy-Borst Side-Arm Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Tuohy-Borst Side-Arm Introducers because the sheath may separate at the proximal bond site, potentially causing life-threatening adverse events.
Product
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, potentially causing life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··2020-12-30
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk
Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.
Product
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
Category
Distribution
51 states
SevereFDA (Devices)··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.
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.
Category
Distribution
51 states