FDA Device Recall Z-0038-2025: 3M Company Health Care Business 3m Center

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2025.

Recall Res Number

Z-0038-2025

Recalling Firm / Manufacturer

3M Company Health Care Business 3m Center

FEI Number

2110898

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-14

Date Posted

2024-10-09

Date Terminated

N/A

Product Code

FRO

Event Number

95273

Product Quantity

10,000 units

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

Reason for Recall Contamination with foreign substance matter

Action Details 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.

Distribution Pattern International distribution to the country of South Korea.

Code Information / Serial Numbers UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

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Medical Device Recall: Z-0038-2025

Recall Parameters & Description

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