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Open, Classified

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

FDA Recall Z-0038-2025 · Posted 2024-10-09

Recalling Firm3M Company - Health Care Business
Recall StatusOpen, Classified
Product CodeFRO
Date Initiated2024-08-14
Product Quantity10,000 units

Reason for Recall

Contamination with foreign substance matter

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.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the country of South Korea.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K2008353M Tegaderm CHG Chlorhexidine Gluconate Gel Pad3M Company · 2020-09-04K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017-07-11K1534103M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing3M Company · 2017-05-15K1236793M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING3M Company · 2013-02-28K080620MODIFICATION TO 3M TEGADERM CHG DRESSING3M Company-3M Health Care · 2008-05-19K0634583M TEGADERM CHG DRESSING3M Company · 2007-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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