Recall Z-0010-2025 ยท FPA Set, Administration, Intravascular
Smiths Medical ASD Inc.
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
| Date | Oct 18, 2024 (initiated Jun 26, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 125928 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081156 | CADD MEDICATION CASSETTE RESERVOIR Smiths Medical MD, Inc., Jul 18, 2008 |