BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 3000057376, 3000063289
- 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:
- Datascope Corporation
- Reason for Recall:
- The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Product Codes/Lot Numbers:
Lot 3000057376, 3000063289
Distribution:
Distributed in: AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1730-2018
Related Recalls
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The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.