Z-1005-2015Class II

Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8

Name: Z-1005-2015 Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8
Creator: Arrow International Inc
Published: 2014-12-16
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2014-12-16 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of 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... on 2014-12-16. FDA classified it as Class II and gives the reason as "the Instructions for Use (IFU) were inadvertently removed from the kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1005-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Posted: 2015-01-22
Terminated: 2015-08-10
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: the Instructions for Use (IFU) were inadvertently removed from the kit.
Root cause tag: labeling and UDI
FDA 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 in commerce: 420
Distribution: In the state of KY
Product codes and lots: 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:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1005-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1005-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-28	2015-01-21

Product code FOZ

K071538Class IIArrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. / cleared 2007-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)