Arrow International, Inc., Division of Teleflex Me Recall: Percutaneous Insertion Tray; Pr
Arrow International, Inc., Division of Teleflex Me Recall: Percutaneous Insertion Tray; Pr is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Arrow International, Inc., Division of Teleflex Medical Inc.; Product: Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utili
| Recalling firm | Arrow International, Inc., Division of Teleflex Medical Inc. |
|---|---|
| Product | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle. |
| Reason for recall | The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panam |
| Recall initiated | 20160210 |
| Recall number | Z-1062-2016 |
| Category | device |
| State | MA |
| Country | United States |
$29/mo
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