CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report

Brand Name Burn Navigator¿ recalled by Arcos

Arcos is recalling Brand Name Burn Navigator¿, distributed in Arizona, Louisiana, Maryland, Oregon, Texas, Washington. The recall was initiated on 16 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe Battery Packs are referred to as component number CMP-1523 in the Burn Navigator User's Manual). The Model/Catalog Numbers 1120 and 1125 are associated with the Burn Navigator H2. Model 1120 (Qty 20) Model 1125 (Qty 8) 2EKSA25422 3HKSB54129 2GKSA30512 3HKSB54132 2GKSA30513 3HKSB54136 2GKSA31162 3HKSB54143 2JKSA37073 4BKSA60753 2JKSA37077 4BKSA60758 2JKSA37465 4BKSA60776 2JKSA37887 4BKSA60786 2LKSA43100 2LKSA43540 2LKSA43541 3FKSB51215 3FKSB51217 3HKSB54006 3HKSB54008 3HKSB54115 3HKSB54140 3HKSB54142 4CKSA61744 4CKSA61752 Battery Models and Lot Numbers: Model: CF-VZSU53AW CF-VZSU53AR CF-VZSU53AQ 4 digit alphanumeric Panasonic Lot Numbers beginning with: B**** C1** C2** C3** C4** C5** C6** C7** C8** C93* C94* C96* C9C* C9J* C9K*

Quantity recalled28

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2295-2019
FDA event ID: 81594
Recalling firm: Arcos, Missouri City, TX
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2015
FDA classified: 21 Aug 2019
Reported: 28 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Mar 2015	Recall initiated by company
21 Aug 2019	Classified by FDA	+1619 days
28 Aug 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Battery packs may heat up abnormally and ignite in rare instance.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523

Where it was distributed

US: AZ, LA, OR, MD, TX, and WA. OUS: No products were distributed outside the US.

Arizona Louisiana Maryland Oregon Texas Washington

Questions about this recall

Is Brand Name Burn Navigator¿ recalled?

Yes. Arcos recalled Brand Name Burn Navigator¿ on 16 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-2295-2019.

Why was it recalled?

Battery packs may heat up abnormally and ignite in rare instance.

Which lots are affected?

The Battery Packs are referred to as component number CMP-1523 in the Burn Navigator User's Manual). The Model/Catalog Numbers 1120 and 1125 are associated with the Burn Navigator H2. Model 1120 (Qty 20) Model 1125 (Qty 8) 2EKSA25422 3HKSB54129 2GKSA30512 3HKSB54132 2GKSA30513 3HKSB54136 2GKSA31162 3HKSB54143 2JKSA37073 4BKSA60753 2JKSA37077 4BKSA60758 2JKSA37465 4BKSA60776 2JKSA37887 4BKSA60786 2LKSA43100 2LKSA43540 2LKSA43541 3FKSB51215 3FKSB51217 3HKSB54006 3HKSB54008 3HKSB54115 3HKSB54140 3HKSB54142 4CKSA61744 4CKSA61752 Battery Models and Lot Numbers: Model: CF-VZSU53AW CF-VZSU53AR CF-VZSU53AQ 4 digit alphanumeric Panasonic Lot Numbers beginning with: B**** C1** C2** C3** C4** C5** C6** C7** C8** C93* C94* C96* C9C* C9J* C9K*

Where was it sold?

US: AZ, LA, OR, MD, TX, and WA. OUS: No products were distributed outside the US.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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