PlainRecalls
FDA Devices Critical Class I Ongoing

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 2

Reported: February 8, 2023 Initiated: December 9, 2022 #Z-0963-2023

Product Description

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP

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

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
45285351 units
Distribution
Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR, AT, BE, IT, DK, NO, EE, DE, NL, AU, GB, SE, PL, SA, IN, IL, PT, CZ, IE, NZ, LU, SI, ZA, BM, SG, MQ, CL, LB, MY, HU, JP, TW, and CN
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled? ▼
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-7383-24, 15) REF 21-7390-24, 16) REF 21-7391-24, 17) REF 21-7394-24, 18) REF 21-7395-24, 19) REF 21-7301-24JP, 20) REF 21-7302-24JP, 21) REF 21-7321-24JP, 22) REF 21-7322-24JP, 23) REF 21-7359-24JP, 24) REF 21-7394-24JP. Recalled by Smiths Medical ASD Inc.. Units affected: 45285351 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Critical. Recall number: Z-0963-2023.

Related Recalls

FDA Devices Moderate

Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…

Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…

Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…

Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…

Fujirebio Diagnostics, Inc. · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →