🔍 RecallPedia

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2018 Custom Healthcare Systems Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    (1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021
  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:
Custom Healthcare Systems, Inc.
Reason for Recall:
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

(1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269

Product Codes/Lot Numbers:

(1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0249-2019

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