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 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF

Reported: February 8, 2023 Initiated: December 9, 2022 #Z-0966-2023

Product Description

CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. 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

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
47595495 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 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 21-7359-24, 15) REF 21-7363-24, 16) REF 21-7383-24, 17) REF 21-7391-24, 18) REF 21-7394-24, 19) REF 21-7600-24, 20) REF 21-7609-24, 21) REF 21-7624-24, 22) REF 21-7649-24, 23) REF 21-7301-24JP, 24) REF 21-7302-24JP, 25) REF 21-7308-24JP, 26) REF 21-7309-24JP, 27) REF 21-7322-24JP, 28) REF 21-7359-24JP, 29) REF 21-7394-24JP, 30) REF 21-7600-24JP, 31) REF 21-7609-24JP, 32) REF 21-7624-24JP, 33) REF 21-7649-24JP. Computerized Ambulatory Delivery Device. Recalled by Smiths Medical ASD Inc.. Units affected: 47595495 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-0966-2023.