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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7308-24, UDI/DI 30610586032374, Lot numbers: 4053922 through 4334076; 5) REF 21-7309-24, UDI/DU 30610586032381, Lot numbers: 4062405 though 4334085; 6) REF 21-7310-24, UDI/DU 30610586032398, Lot numbers: 4062404 through 4330874; 7) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 8) REF 21-7323-24, UDI/DI 30610586039618, Lot numbers: 3776373 through 4334325; 9) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 10) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7346-24, UDI/DI 35019517161957, Lot numbers: 3776356 through 4320785; 13) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 14) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 15) REF 21-7363-24, UDI/DI 35019517161964, Lot numbers: 3773412 through 4334343; 16) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 17) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 18) REF 21-7394-24, UDI/DI 30610586027530, Lot number: 3774739 through 4339178; 19) REF 21-7600-24, UDI/DI 30610586044001, Lot numbers: 4084914 through 4329633; 20) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; 21) REF 21-7624-24, UDI/DI 30610586044742, Lot numbers: 4092506 through 4309481; 22) REF 21-7649-24, UDI/DI 35019517184246, Lot numbers: 4076410 through 4334357. 23) REF 21-7301-24JP, UDI/DI N/A, Lot Numbers: 3630747 through 4334113; 24) REF 21-7302-24JP, UDI/DI N/A, Lot Numbers: 3617363 through 4329630; 25) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; 26) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870; 27) REF 21-7322-24JP, UDI/DI N/A, Lot Numbers: 3776375 through 4334324; 28) REF 21-7359-24JP, UDI/DI N/A, Lot Numbers: 3776315 through 4334339; 29) REF 21-7394-24JP, UDI/DI N/A, Lot Numbers: 3774739 through 4339178; 30) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633; 31) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; 32) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; 33) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
1) REF 21-7300-24, UDI/DI 30610586027196, Lot Number: 3630772 through 4334107; 2) REF 21-7301-24, UDI/DI 30610586027219, Lot numbers: 3630747 through 4334119; 3) REF 21-7302-24, UDI/DI 30610586027233, Lot numbers: 3617363 through 4334138; 4) REF 21-7308-24, UDI/DI 30610586032374, Lot numbers: 4053922 through 4334076; 5) REF 21-7309-24, UDI/DU 30610586032381, Lot numbers: 4062405 though 4334085; 6) REF 21-7310-24, UDI/DU 30610586032398, Lot numbers: 4062404 through 4330874; 7) REF 21-7322-24, UDI/DI 30610586029640, Lot numbers: 3776375 through 4334324; 8) REF 21-7323-24, UDI/DI 30610586039618, Lot numbers: 3776373 through 4334325; 9) REF 21-7324-24, UDI/DI 30610586029657, Lot numbers: 3773527 through 4334328; 10) REF 21-7333-24, UDI/DI 30610586043233, Lot numbers: 3776362 through 3984144; 11) REF 21-7343-24, UDI/DI 35019517191824, Lot numbers: 3965344 through 4334338; 12) REF 21-7346-24, UDI/DI 35019517161957, Lot numbers: 3776356 through 4320785; 13) REF 21-7349-24, UDI/DI 35019517184239, Lot numbers: 3926579 through 4339160; 14) REF 21-7359-24, UDI/DI 30610586027400, Lot numbers: 3776315 through 4334339; 15) REF 21-7363-24, UDI/DI 35019517161964, Lot numbers: 3773412 through 4334343; 16) REF 21-7383-24, UDI/DI 30610586027479, Lot numbers: 3780549 through 3971523; 17) REF 21-7391-24, UDI/DI 30610586027516, Lot numbers: 3773276 through 4334351; 18) REF 21-7394-24, UDI/DI 30610586027530, Lot number: 3774739 through 4339178; 19) REF 21-7600-24, UDI/DI 30610586044001, Lot numbers: 4084914 through 4329633; 20) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; 21) REF 21-7624-24, UDI/DI 30610586044742, Lot numbers: 4092506 through 4309481; 22) REF 21-7649-24, UDI/DI 35019517184246, Lot numbers: 4076410 through 4334357. 23) REF 21-7301-24JP, UDI/DI N/A, Lot Numbers: 3630747 through 4334113; 24) REF 21-7302-24JP, UDI/DI N/A, Lot Numbers: 3617363 through 4329630; 25) REF 21-7308-24JP, UDI/DI N/A, Lot Numbers: 4053922 through 4334075; 26) REF 21-7309-24JP, UDI/DI N/A, Lot Numbers: 4062405 through 4330870; 27) REF 21-7322-24JP, UDI/DI N/A, Lot Numbers: 3776375 through 4334324; 28) REF 21-7359-24JP, UDI/DI N/A, Lot Numbers: 3776315 through 4334339; 29) REF 21-7394-24JP, UDI/DI N/A, Lot Numbers: 3774739 through 4339178; 30) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633; 31) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; 32) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; 33) REF 21-7649-24JP, UDI/DI N/A, Lot Numbers: 4076410 through 4334357.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0966-2023
Related Recalls
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.