3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
FDA device recall Z-0038-2025 · posted 2024-10-09 · Open, Classified
Recall details
- Recalling firm
- 3M Company - Health Care Business
- Reason for recall
- Contamination with foreign substance matter
- Action taken
- 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
- Status
- Open, Classified
- Product code
- FRO
- Quantity affected
- 10,000 units
- Distribution
- International distribution to the country of South Korea.
- Date initiated
- 2024-08-14
- Date posted
- 2024-10-09
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad (K200835) | 3M Company | 2020-09-04 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K171908) | 3M Company | 2017-07-11 |
| 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K153410) | 3M Company | 2017-05-15 |
| 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING (K123679) | 3M Company | 2013-02-28 |
| MODIFICATION TO 3M TEGADERM CHG DRESSING (K080620) | 3M Company-3M Health Care | 2008-05-19 |
| 3M TEGADERM CHG DRESSING (K063458) | 3M Company | 2007-04-05 |