Recall Z-0038-2025— 3M Company - Health Care Business
Class II · Ongoing
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2024-08-14. It names 6 FDA 510(k) clearances: K200835, K171908, K153410 and 3 more. Product: 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R. Reason: Contamination with foreign substance matter.
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-14
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
6 on FDA's record- K200835 — 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
- K171908 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
- K153410 — 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
- K123679 — 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
- K080620 — MODIFICATION TO 3M TEGADERM CHG DRESSING
- K063458 — 3M TEGADERM CHG DRESSING
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Reason for recall
Contamination with foreign substance matter
Data sourced from openFDA. This site is unofficial and independent of the FDA.