Recall Z-0038-2025 ยท FRO Dressing, Wound, Drug
3M Company - Health Care Business
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
| Date | Oct 9, 2024 (initiated Aug 14, 2024) |
| Status | Open, Classified |
| Reason | Contamination with foreign substance matter |
| 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 | 10,000 units |
| Distribution | International distribution to the country of South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063458 | 3M TEGADERM CHG DRESSING 3M Company, Apr 5, 2007 |
| K080620 | MODIFICATION TO 3M TEGADERM CHG DRESSING 3M Company-3M Health Care, May 19, 2008 |
| K123679 | 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING 3M Company, Feb 28, 2013 |
| K153410 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M Company, May 15, 2017 |
| K171908 | 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M Company, Jul 11, 2017 |
| K200835 | 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad 3M Company, Sep 4, 2020 |