FDA Medical devices recall ·
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 recall
- Recall number
- Z-0018-2025
- Date
- (initiated June 26, 2024)
- Company / brand
- Smiths Medical ASD, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 120960 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Why was it recalled?
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 30610586044186, Lot Numbers: 3997242-ENG, 4040002AB, 4040000AB, 4040001AB, 4040008AB, 4040007AB, 4040009AB, 4146021AB
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0018-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.