Z-2555-2019Class II

8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters

Name: Z-2555-2019 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters
Creator: Arrow International Inc
Published: 2019-08-06
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-08-06 / Terminated / root cause: packaging

FDA source

Arrow International Inc began a recall of 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central... on 2019-08-06. FDA classified it as Class II and gives the reason as "Products may contain the incorrect banner card within the kit". 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-2555-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Posted: 2019-09-23
Terminated: 2020-09-29
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Product code: DYB Introducer, Catheter
Reason for recall: Products may contain the incorrect banner card within the kit
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Arrow International issued notification dated 8/6/19 stating problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. 4. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 520 eaches
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number: 13F18H0610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2555-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2555-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-23
Z-2556-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-02	2019-09-23

Product code DYB

K011761Class IIMac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis Valve/side PortArrow Intl., Inc. / cleared 2001-10-31

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)