🔍 RecallPedia

Lamicel 20PK 3MM INTL Cervical dilator

Class I - Dangerous
🏥 Medical Devices Recalled: November 13, 2019 Medtronic Xomed Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
  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:
Medtronic Xomed, Inc.
Reason for Recall:
Routine sterilization dose does not meet the required Sterility Assurance Level.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Lamicel 20PK 3MM INTL Cervical dilator

Product Codes/Lot Numbers:

UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0733-2020

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