CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 409963, 409964, 409965, 409966, 409967, 409968, 409969, 409970, 409971, 409972, 409973, 409974, 409975, 409976, 409977, 409978, 409979, 409980, 409981, 409982, 409983, 409984, 409985, 409986, 409987, 409988, 409989, 409990, 409991, 409992, 409993, 409994, 409995, 409996, 409997, 409998, 409999, 410000, 410001, 410002, 410003, 410004, 410005, 410006, 410007, 410008, 410009, 410010, 410011, 410012, 410013, 410014, 410015, 410016, 410017, 410018, 410019, 410020
- 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:
- Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Product Codes/Lot Numbers:
Serial Numbers: 409963, 409964, 409965, 409966, 409967, 409968, 409969, 409970, 409971, 409972, 409973, 409974, 409975, 409976, 409977, 409978, 409979, 409980, 409981, 409982, 409983, 409984, 409985, 409986, 409987, 409988, 409989, 409990, 409991, 409992, 409993, 409994, 409995, 409996, 409997, 409998, 409999, 410000, 410001, 410002, 410003, 410004, 410005, 410006, 410007, 410008, 410009, 410010, 410011, 410012, 410013, 410014, 410015, 410016, 410017, 410018, 410019, 410020
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0307-2018
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.