Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
FDA Recall Z-1005-2015 · Posted 2015-01-22
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2014-12-16
Date Terminated2015-08-10
Product Quantity420
Reason for Recall
the Instructions for Use (IFU) were inadvertently removed from the kit.
Firm Action
An Urgent Medical Device Corrective Action Notification letter, dated December 16, 2014, was sent to Owens & Minor, 1605 Worldwide Blvd., Hebron, KY 41048-8653, instructing them to immediately discontinue distribution and quarantine any products, use customer letter and Corrective Action Acknowledgement Form templates to communicate this corrective action to any of thier customers that have received product included within the scope of the corrective action, and to have their customers return a completed Corrective Action Acknowledgement Form outlining their remaining inventory of the affected product codes and lot numbers for which replacement IFUs is needed.
Root Cause
Labeling False and Misleading
Distribution Pattern
In the state of KY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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