# K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Mar 8, 2000 after 128 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 22 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
133 later devices descend from it; 6 cite it directly.
16 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ARROWg*ard Blue® Antimicrobial Multi-Lumen Central Venous Catheter: named in the summary without a submission number

## Most influential descendants
- K021557: Spectrum Silicone Catheter (2003), 126 descendants of its own
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line (2005), 119 descendants of its own
- K070996: 4 FR Single Lumen (SL) Powerpicc Catheter (2007), 66 descendants of its own
- K061179: Powerhickman Long-Term Intravascular Catheter (2006), 47 descendants of its own
- K091953: Pro-Picc (2009), 29 descendants of its own

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2376-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect
- Jan 6, 2021 · Class II · Z-1106-2021: 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 ide
- Jul 18, 2019 · Class II · Z-0192-2020: Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length
- Sep 21, 2018 · Class II · Z-0468-2019: The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size
- Aug 30, 2018 · Class II · Z-0282-2019: The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifi
- Apr 11, 2018 · Class II · Z-2003-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2002-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2001-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2005-2018: Product sterility may be compromised due to unsealed packaging.
- Apr 11, 2018 · Class II · Z-2004-2018: Product sterility may be compromised due to unsealed packaging.
- Dec 22, 2017 · Class II · Z-1335-2018: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
- Dec 21, 2017 · Class II · Z-1152-2018: Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.
- Oct 17, 2017 · Class II · Z-0656-2018: These finished good kits may contain the incorrect Springwire Guide (SWG).
- May 9, 2017 · Class II · Z-2332-2017: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
- Jul 17, 2013 · Class II · Z-1507-2014: Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM cath
- Jul 29, 2010 · Not classified · Z-2493-2010: Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
- Nov 24, 2009 · Not classified · Z-0786-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Nov 24, 2009 · Not classified · Z-0785-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Nov 24, 2009 · Not classified · Z-0788-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Nov 24, 2009 · Not classified · Z-0787-2010: Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
- Feb 11, 2009 · Not classified · Z-1498-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.
- Sep 27, 2004 · Not classified · Z-0059-05: Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK

## Indications for use
The ARROWGg'ard Blue Plus™ antimicrobial catheter is indicated in the short-term (<30 day) treatment of diseases or conditions requiring central venous access, including, but not limited to the following: multiple peripheral sites for IV access lack of usable peripheral IV sites central venous pressure monitoring total parenternal nutrition (TPN) incompatible medications multiple infusions of fluids, medications, or chemotherapy frequent blood sampling or receiving blood transfusions/blood products infusions that are hypertonic, hyperosmolar, or infusions that have divergent pH values There are no specific COC guidelines for maximum indwelling times or catheter exchanges. Catheters should remain indwelling or should be exchanged per hospital protocol.

Source page: https://510kreport.com/device/K993691
Methodology: https://510kreport.com/methodology