🔍 RecallPedia

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2023 Wilson-Cook Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00827002227651 (each), 10827002227658 (case), Lot Numbers: W4721269, W4721794, W4722640, W4722986, W4723306, W4723844, W4723847, W4724322, W4739837, W4740113, W4742111, W4742513, W4742524, W4743194, W4743197, W4744442, W4744872, W4744873, W4748250, W4751513, W4751773, W4752903, W4753813, W4753820, W4753821, W4754252, W4755365, W4756464, W4756475, W4757731, W4757734, W4758163, W4758168, W4758649, W4758931, W4759974, W4759978, W4760297, W4760463, W4760464, W4760466, W4760720, W4760859, W4761739, W4761741, W4762144, W4762624
  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:
Wilson-Cook Medical Inc.
Reason for Recall:
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

Product Codes/Lot Numbers:

UDI/DI 00827002227651 (each), 10827002227658 (case), Lot Numbers: W4721269, W4721794, W4722640, W4722986, W4723306, W4723844, W4723847, W4724322, W4739837, W4740113, W4742111, W4742513, W4742524, W4743194, W4743197, W4744442, W4744872, W4744873, W4748250, W4751513, W4751773, W4752903, W4753813, W4753820, W4753821, W4754252, W4755365, W4756464, W4756475, W4757731, W4757734, W4758163, W4758168, W4758649, W4758931, W4759974, W4759978, W4760297, W4760463, W4760464, W4760466, W4760720, W4760859, W4761739, W4761741, W4762144, W4762624

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0461-2024

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Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

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