Z-1106-2021Class II

Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way...

Name: Z-1106-2021 Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way...
Creator: Arrow International Inc
Published: 2021-01-06
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2021-01-06 / Terminated

FDA source

Arrow International Inc began a recall of Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins... on 2021-01-06. FDA classified it as Class II and gives the reason as "The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1106-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-06
Posted: 2021-02-10
Terminated: 2022-07-12
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
FDA root cause: Under Investigation by firm
Action: Arrow International issued Urgent Medical Device Correction notification letter on 6th Jan 2021 via FedEx 2-day mail.Letter states reason for recall, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 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]. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 1,705 eaches
Distribution: US Nationwide
Product codes and lots: Lot Code: 13F20E0173

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1106-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1106-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-10

Product code FOZ

K993691Class IIArrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. / cleared 2000-03-08

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)