CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report

3M Tegaderm CHG, Chlorhexidine Gluconate I.V recalled

3M Company - Health Care Business is recalling 3M Tegaderm CHG, Chlorhexidine Gluconate I.V, distributed nationwide in the US. The recall was initiated on 14 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

Quantity recalled10,000 units

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-0038-2025
FDA event ID: 95273
Recalling firm: 3M Company - Health Care Business, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 14 Aug 2024
FDA classified: 9 Oct 2024
Reported: 16 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Aug 2024	Recall initiated by company
9 Oct 2024	Classified by FDA	+56 days
16 Oct 2024	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

Contamination with foreign substance matter

Product as listed by the FDA

3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Where it was distributed

International distribution to the country of South Korea.

Nationwide

Questions about this recall

Is 3M Tegaderm CHG, Chlorhexidine Gluconate I.V recalled?

Yes. 3M Company - Health Care Business recalled 3M Tegaderm CHG, Chlorhexidine Gluconate I.V on 14 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0038-2025.

Why was it recalled?

Contamination with foreign substance matter

Which lots are affected?

UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

Where was it sold?

International distribution to the country of South Korea.

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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