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Shiley

Covidien LP · Model 125239 · UDI-DI 10884522008792

BTS Prescription
1
510(k) clearances
2,485
Adverse events (5 deaths)
11
Recalls
11
Facilities

Description

Endobronchial Tube Left with Carinal Hook;Endobronchial Suction Catheter;Endobronchial Tube Accessories

Recalls

DateFirmReason
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-11-21Teleflex, Inc.Customer complaints reporting that the cobb connector detached from the main connector prior to use.
2014-02-28Teleflex MedicalThe product may fail to achieve seal of right lung due to the cuff inflating to one side

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.