Check-Flo Performer Introducer Set white caps may disconnect
Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a medical device with a functional defect (white caps may disconnect) that poses a risk of device failure during medical procedures. No hospitalizations or injuries are reported in the source, qualifying this as a risk-of-harm product where injury has not yet been reported, per the rubric criterion for Score 3 (High).
Plain-English summary
Cook Incorporated is recalling a lot of Check-Flo Performer Introducer Sets. The Performer Introducer is a medical device designed to function as a guiding sheath and/or introducer sheath and includes a Check Flo valve.
Cook Medical initiated this recall due to complaints that the white caps connecting the shaft to the hub of these products may disconnect. A disconnection could compromise the device's integrity during use.
The affected product lot consisted of 50 units with Lot Number 15506769 (UDI-DI: 00827002272422, Reference Part Number RCF-5.0-35-45-J, Order Number G27242). These units were distributed to Australia.
If you have the affected product, contact Cook Incorporated for guidance on the recall or with questions about your product.
The recalled product
- Product
- Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
- Manufacturer
- Cook Incorporated
- Hazard
- Affected units
- 50
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 (2)
- UDI-DI: 00827002272422
- Lot Number: 15506769
Distribution
Distribution scope not specified by the agency.
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