Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving mislabeling of device caliber size. While a sizing mismatch in vascular introducers could result in access complications, no illnesses or injuries have been reported. Per the rubric, labeling errors without documented harm receive Moderate severity.
Plain-English summary
Cook Inc. is recalling the Flexor Check-Flo Introducer Ansel Modification (Model KCFW-7.0-18/38-45-RB-ANL0-HC) due to mislabeling of the device caliber size. Products packaged with labels indicating 6FR may contain 7FR devices, and packages labeled 7FR may contain 6FR devices. This mismatch between the package label and the actual device size could lead to incorrect device selection during clinical procedures.
The Flexor Check-Flo Introducer is used to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Forty-seven units were affected and distributed to healthcare facilities in Alabama, Arizona, California, Florida, Georgia, Kansas, Michigan, Missouri, Minnesota, North Carolina, New York, Oklahoma, and Texas. Additional units were distributed internationally to Belgium, Switzerland, Germany, Spain, France, United Kingdom, Guam, Italy, and South Africa. The affected lot number is 13911710.
Healthcare providers who have received affected products should verify the actual caliber of devices before clinical use. Facilities should contact Cook Inc. for instructions regarding the mislabeled products and any necessary replacement or corrective actions.
The recalled product
- Product
- Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
- Manufacturer
- Cook Inc.
- Hazard
- mislabeling
- sizing-mismatch
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: 13911710 UDI: (01)00827002441552(17)240422(10)13911710
Distribution
Distributed in 15 states:
- AL
- AZ
- CA
- DE
- FL
- GA
- GU
- KS
- MI
- MN
- MO
- NC
- NY
- OK
- TX
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