ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
FDA device recall Z-0018-2025 · posted 2024-10-18 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- 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.
- Action taken
- Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: productcomplaints@icumed.com 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 tsc.support@icumed.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 120960 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-06-26
- Date posted
- 2024-10-18
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD MEDICATION CASSETTE RESERVOIR (K081156) | Smiths Medical MD, Inc. | 2008-07-18 |