Z-1332-2018Class II

(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN...

Name: Z-1332-2018 (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN...
Creator: Arrow International Inc
Published: 2017-12-22
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-12-22 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen... on 2017-12-22. FDA classified it as Class II and gives the reason as "Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1332-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Posted: 2018-04-10
Terminated: 2020-05-27
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
Product code: DQY Catheter, Percutaneous
Reason for recall: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.
Distribution: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Product codes and lots: Lot Numbers: (1) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1332-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1323-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1324-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1325-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1326-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1327-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1328-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1329-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1330-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1331-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1332-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1333-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1334-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1335-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1336-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code DQY

K862056Class II[Central Venous][multi-Lumen] Catheter W/flex TipArrow Intl., Inc. / cleared 1986-08-25

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)