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Terminated

T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation

FDA Recall Z-1801-2015 · Posted 2015-06-15

Recalling FirmVidacare Corporation
Recall StatusTerminated
Product CodeFMI
Date Initiated2015-05-12
Date Terminated2016-04-11
Product Quantity2,104 boxes

Reason for Recall

Potential breach in sterility

Firm Action

Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990.

Root Cause

Device Design

Distribution Pattern

US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120661THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACREVidacare Corporation · 2012-06-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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