510(k) · Cleared
Recalled · Class I · 2026Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 8, 2000 after a 128-day review. The FDA summary names its predicate without a number. 16 of the 134 devices in its family, counting itself, have a Class I recall. 133 later devices descend from it. It has been recalled 22 times, including a Class I recall.
- Decided
- Mar 8, 2000
- Review
- 128 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 22 (1 Class I)
- Predicates
- 0
133 later devices descend from it, 6 citing it directly. 16 of the 134 devices in this family, counting this one, have a Class I recall.
- This deviceK993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous…Arrow Intl., Inc. · 2000
- Descendant · cites it directly · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- Descendant · 2 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- Descendant · 3 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- Descendant · 3 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
- Descendant · 4 generations on · 29 of its ownK091953 Pro-PiccMedcomp · 2009
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 133 · See all- K021557Spectrum Silicone CatheterCook, Inc. · 2003 · cites it directly126descendants
- K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 2 generations on119descendants
- K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 3 generations on66descendants
- K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 3 generations on47descendants
- K091953Pro-PiccMedcomp · 2009 · 4 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter | Arrow Intl., Inc. | 2000 | — |
| +1 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| +2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| +3 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| +3 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
| +4 | K091953 | Pro-Picc | Medcomp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 1 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 1 |
| 2011 | 5 | 0 |
| 2012 | 16 | 3 |
| 2013 | 14 | 2 |
| 2014 | 13 | 2 |
| 2015 | 7 | 2 |
| 2016 | 13 | 2 |
| 2017 | 4 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 1 | 1 |
| 2022 | 3 | 1 |
| 2023 | 3 | 0 |
| 2025 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
16 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ARROWg*ard Blue® Antimicrobial Multi-Lumen Central Venous Catheter Named without a submission number |
What descends from it? (133)
See all 1336 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021557 | Spectrum Silicone Catheter | 2003 | 126 |
| K071538 | Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter Class I | 2007 | 14 |
| K024007 | Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30J | 2003 | 2 |
| K093489 | IN Vision-Plus Nano with Neutral Advantage Technology | 2010 | 0 |
| K073520 | Angiotech CVC | 2008 | 0 |
| K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion… | 2006 | 0 |
Has anything in its family been recalled? (16 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2376-2026 | Nonconforming Material/Component | 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 ineffectiveness, and if sterility of a… |
| Jan 6, 2021 | Class II | Z-1106-2021 | Under Investigation by firm | 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… |
| Jul 18, 2019 | Class II | Z-0192-2020 | Packaging process control | 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 | Employee error | 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 .025 . For other lots in scope the… |
| Aug 30, 2018 | Class II | Z-0282-2019 | Under Investigation by firm | 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 identifies an incorrect expiration date. Per… |
| Apr 11, 2018 | Class II | Z-2003-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2002-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2001-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2005-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2004-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1335-2018 | Process control | 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 | Process control | 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 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| May 9, 2017 | Class II | Z-2332-2017 | Packaging | 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 | Labeling False and Misleading | 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 catheter, while the rest of the lidstock… |
| Jul 29, 2010 | Not classified | Z-2493-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Nov 24, 2009 | Not classified | Z-0786-2010 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Device Design | 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 | Other | 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 |
The 5 latest of 22 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- Of its descendants, K021557 (Cook, Inc., 2003) has gone furthest, with 126 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993691 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993691: Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993691
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026