Z-1160-2018Class II

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps...

Name: Z-1160-2018 Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps...
Creator: Arrow International Inc
Published: 2017-11-14
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2017-11-14 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions... on 2017-11-14. FDA classified it as Class II and gives the reason as "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line...". 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-1160-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-14
Posted: 2018-03-05
Terminated: 2019-07-15
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
Product code: DYB Introducer, Catheter
Reason for recall: Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to [email protected]. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in commerce: 18,124 total
Distribution: Nationwide Distribution
Product codes and lots: ASK-29803-SJH 13F16K0136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1160-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1158-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1159-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1160-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1161-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1162-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1163-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1164-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1165-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1166-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22

Product code DYB

K940079Class IIArrow Percutaneous Sheath Introducer Kit Ak-07903Arrow Intl., Inc. / cleared 1994-11-30

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)