Z-1128-2010

Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection...

Name: Z-1128-2010 Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection...
Creator: Arrow International Inc
Published: 2010-02-01
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2010-02-01 / Terminated / root cause: design

FDA source

Arrow International Inc began a recall of Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks... on 2010-02-01. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1128-2010
Status: Terminated
Initiated: 2010-02-01
Posted: 2010-03-30
Terminated: 2012-11-08
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Sterility may be compromised.
Root cause tag: design
FDA root cause: Component design/selection
Action: The recalling firm issued an "Urgent Medical Device Recall" letter dated February 19, 2010 to their consignees to inform them of the issue. Customers were instructed to check their inventory for the affected products, cease use and distribution, and quarantine all affected product immediately. Consignees were further instructed the following: 1) Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the completed form to Arrow International at 1-800-343-2935 and 2) Return all affected product to Arrow International, Inc. 312 Commerce Place, Asheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. If additional information or clarification regarding the recall is needed, please contact Arrow International, Customer Service Department at 1-800-523-8446. Details about the recall can be accessed on the firm's website at http://www.teleflexmedical.com/spotlight/ivTubingRecall/index.html.
Quantity in commerce: 70,959,969 of total units
Distribution: Worldwide Distribution -- United States, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom.
Product codes and lots: Product numbers MPI-17894, MPI-17895, MPI-17897, MPI-17899, MPI-17927, and MPI-18054.

Product code FPA

K830755Class IIi.v. Sets Walrus Brand Various Configur-Medical Parameters, Inc. / cleared 1983-04-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)