Recall Z-0012-2025— Smiths Medical ASD Inc.

Name: FDA recall Z-0012-2025
Creator: U.S. Food and Drug Administration
Published: 2024-06-26

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, 100mL, FS, YELLOW, Product Code 21-7300-24. 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 record

K081156 — CADD MEDICATION CASSETTE RESERVOIRSmiths Medical MD, Inc.·cleared 2008-07-18

K-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, 100mL, FS, YELLOW, Product Code 21-7300-24

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.