High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog number/FG Item Number: 0263A-00 1. No lots for cracking issue identified (0 Distributed). 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
- 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:
- Haemonetics Corporation
- Reason for Recall:
- Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Product Codes/Lot Numbers:
Catalog number/FG Item Number: 0263A-00 1. No lots for cracking issue identified (0 Distributed). 2. Missing instructions to check for cracks in IFU All products/lost manufactured between October 2014 and October 2019.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0887-2020
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