Z-1118-2019Class II

Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter

Name: Z-1118-2019 Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter
Creator: Arrow International Inc
Published: 2019-01-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-01-10 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132 on 2019-01-10. FDA classified it as Class II and gives the reason as "The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct". 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-1118-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-10
Posted: 2019-04-10
Terminated: 2020-06-04
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
Product code: DQY Catheter, Percutaneous
Reason for recall: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Teleflex issued Urgent Medical Device Notification to US consignee notification letter on 10th January 2019 via FedEx 2-day mail. Actions to be taken to remove product from the facilities: A: The affected customer is instructed to take the following actions: 1. Place a copy of this notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form
Quantity in commerce: None (US)
Distribution: FL, NC
Product codes and lots: Lot Numbers: 71F14E0696 71F14K0658 71F15E0493 71F15L0621 71F14E1541 71F14K1683 71F15F0090 71F15M0787 71F14F1154 71F14L0719 71F15H0574 71F16A0278 71F14H0474 71F14M1375 71F15H1503 71F16B0054 71F14H1215 71F15A0025 71F15J0570 71F16B1306 71F14J0852 71F15A1592 71F15J2098 71F14J1889 71F15D1460 71F15L0153

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1118-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1118-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10
Z-1119-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10

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