Z-1818-2019Class II

Arrowg+ard Blue Advance Midline

Name: Z-1818-2019 Arrowg+ard Blue Advance Midline
Creator: Arrow International Inc
Published: 2019-04-23
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-04-23 / Terminated / root cause: manufacturing process

FDA source

Arrow International Inc began a recall of Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS on 2019-04-23. FDA classified it as Class II and gives the reason as "Lidstock states the incorrect expiration date for the product". 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-1818-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-23
Posted: 2019-06-16
Terminated: 2021-01-13
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
Product code: PND Midline Catheter
Reason for recall: Lidstock states the incorrect expiration date for the product
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 430 units
Distribution: Nationwide Foreign:
Product codes and lots: Batch Code:13F17L0170

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1818-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1787-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1788-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1789-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1790-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1791-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1792-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1793-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1794-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1795-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1796-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1797-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1798-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1799-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1800-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1801-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1802-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1803-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1804-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1805-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1806-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1807-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1808-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1809-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1810-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1811-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1812-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1813-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1814-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1815-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1816-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1817-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1818-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1819-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1820-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1821-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15
Z-1822-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-15

Product code PND

K161313Class IIARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) / cleared 2016-08-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)