Recall Z-0964-2023— Smiths Medical ASD Inc.

Name: FDA recall Z-0964-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-09

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2022-12-09. It names one FDA 510(k) clearance: K081156. Product: CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device. Reason: There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms.

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-12-09
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 Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device

Reason for recall

There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

Data sourced from openFDA. This site is unofficial and independent of the FDA.