Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001
  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:
Trinity Sterile, Inc.
Reason for Recall:
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Product Codes/Lot Numbers:

Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1468-2021

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