Cook Flexor Check-Flo Introducer recalled for size mislabeling
Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device mislabeling recall where packaging size labels (6FR/7FR) do not match actual device contents. No illnesses have been reported, but this sizing discrepancy presents a risk of harm during vascular procedures.
Plain-English summary
Cook Inc. is recalling the Flexor Check-Flo Introducer Ansel Modification due to mislabeled packaging. The device (Model KCFW-6.0-18/38-45-RB-ANL0-HC) is used to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
The recall affects 50 units from Lot Number 13895370. Products packaged with labels stating 6FR may contain 7FR devices, and products labeled 7FR may contain 6FR devices. This mismatch between label and actual device size creates a risk during vascular procedures.
Affected lot was distributed in the United States (Alabama, Arizona, California, Florida, Georgia, Kansas, Michigan, Missouri, Minnesota, North Carolina, New York, Oklahoma, Texas) and internationally (Belgium, Switzerland, Germany, Spain, France, United Kingdom, Guam, Italy, South Africa).
The recalled product
- Product
- Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Manufacturer
- Cook Inc.
- Hazard
- mislabeling
- device-size-error
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 (1)
- Lot Number: 13895370 UDI: (01)00827002441545(17)240415(10)13895370
Distribution
Distributed in 15 states:
- AL
- AZ
- CA
- DE
- FL
- GA
- GU
- KS
- MI
- MN
- MO
- NC
- NY
- OK
- TX
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