Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166 15095289 15095644 15096050 15096443 15086936 15095167 15095327 15095645 15096125 15096515
- 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:
- CareFusion 303, Inc.
- Reason for Recall:
- CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Product Codes/Lot Numbers:
15086733 15086937 15095168 15095332 15095772 15096137 15096516 15086756 15095022 15095212 15095333 15095773 15096183 15096627 15086832 15095045 15095213 15095334 15095842 15096184 15096628 15086833 15095088 15095214 15095347 15095843 15096222 15096629 15086864 15095103 15095254 15095490 15095844 15096291 15096703 15086865 15095128 15095255 15095504 15095936 15096292 15096704 15086910 15095136 15095274 15095505 15096020 15096412 15096722 15086911 15095137 15095275 15095561 15096021 15096413 15096723 15086912 15095166 15095289 15095644 15096050 15096443 15086936 15095167 15095327 15095645 15096125 15096515
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0445-2016
Related Recalls
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.