BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot 3000058734, 3000063711,
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622

Product Codes/Lot Numbers:

Lot 3000058734, 3000063711,

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.gov

FDA Recall Number: Z-1721-2018

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