basixSKY Inflation Device, REF: SKY1802

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to [email protected] If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at [email protected] or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.