Arrow International Inc: 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.

Recall number

Z-1005-2015

Recalling firm

Arrow International Inc

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.

Status

Terminated

Initiated

2014-12-16

Posted

2015-01-22

Terminated

2015-08-10

Reason

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

Root cause

Labeling False and Misleading

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.

Quantity

420

Distribution

In the state of KY

Lot, serial or model codes

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:

510(k) numbers

["K071538"]

PMA numbers

not on file

Product code

FOZ

Firm FEI

3015859709

Firm city

Reading

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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