CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914 through 4329633; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4092506 through 4309481; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4076410 through 4334357; e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633, f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; h) 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: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
Product Codes/Lot Numbers:
a) REF 21-7600-24, UDI/DI 30610586044001, Lot Numbers: 4084914 through 4329633; b) REF 21-7609-24, UDI/DI 30610586044018, Lot Numbers: 4072200 through 4334090; c) REF 21-7624-24, UDI/DI 30610586044742, Lot Numbers: 4092506 through 4309481; d) REF 21-7649-24, UDI/DI 35019517184246, Lot Numbers: 4076410 through 4334357; e) REF 21-7600-24JP, UDI/DI N/A, Lot Numbers: 4084914 through 4329633, f) REF 21-7609-24JP, UDI/DI N/A, Lot Numbers: 4072200 through 4334090; g) REF 21-7624-24JP, UDI/DI N/A, Lot Numbers: 4092506 through 4309481; h) 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-0965-2023
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.