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Recall Observatory FDA recall evidence

Device product

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.

Z-1005-2015

December 16, 2014

Class II

Product summary

Firm
Arrow International Inc
Event
Event 70017
Status
Terminated
Classification
Class II
Quantity
420
Official record key
device-enforcement:Z-1005-2015

Official wording

Reason: the Instructions for Use (IFU) were inadvertently removed from the kit.

Code information: Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:

Distribution pattern: In the state of KY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    the Instructions for Use (IFU) were inadvertently removed from the kit.