Z-0038-2025Class II

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

Name: Z-0038-2025 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Creator: 3M Company - Health Care Business
Published: 2024-08-14
License: https://open.fda.gov/license/

3M Company / initiated 2024-08-14 / Open, Classified

FDA source

3M Company - Health Care Business began a recall of 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R on 2024-08-14. FDA classified it as Class II and gives the reason as "Contamination with foreign substance matter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0038-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-14
Posted: 2024-10-09
Recalling firm: 3M Company
Product: 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Product code: FRO Dressing, Wound, Drug
Reason for recall: Contamination with foreign substance matter
FDA root cause: Under Investigation by firm
Action: 3M notified its sole consignee (a distributor) on 08/14/2024 via email. The notice explained the issue and requested the following: Identify and discontinue distribution of affected product, notify those to whom you distributed the product, and return the product to the seller. The firm provided a letter for the distributor to send to its customers.
Quantity in commerce: 10,000 units
Distribution: International distribution to the country of South Korea.
Product codes and lots: UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0038-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-09

Product code FRO

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)