smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057
- 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:
- Uncertainty in the seal integrity of the sterile packaging.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Product Codes/Lot Numbers:
a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0147-2025
Related Recalls
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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.