🔍 RecallPedia

Surgical Suture Kit

Class I - Dangerous
🏥 Medical Devices Recalled: April 22, 2022 Stradis Healthcare Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
  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:
Stradis Healthcare
Reason for Recall:
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Surgical Suture Kit

Product Codes/Lot Numbers:

Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717

Distribution:

Distributed in: US, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1132-2022

Related Recalls