Oscor Inc. Destino Twist 14F (also branded as Guidestar 14F) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Recommended Action

Per FDA guidance

Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to recall@Oscor.com.

Distribution

As reported by FDA

IN, PA, TN