Recall Z-0014-2025— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2024-06-26. It names one FDA 510(k) clearance: K081156. Product: CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24. 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..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-26
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.