Z-1030-2015Class III

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with...

Name: Z-1030-2015 Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with...
Creator: Arrow International Inc
Published: 2015-01-09
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2015-01-09 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing on 2015-01-09. FDA classified it as Class III and gives the reason as "Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1030-2015
Classification: Class III
Status: Terminated
Initiated: 2015-01-09
Posted: 2015-01-29
Terminated: 2017-08-23
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Product code: OBJ Catheter, Ultrasound, Intravascular
Reason for recall: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.
Quantity in commerce: 4484
Distribution: US (nationwide) and PR.
Product codes and lots: Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1030-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2015	Class III	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-29

Product code OBJ

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)