🔍 RecallPedia

Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Class I - Dangerous
🏥 Medical Devices Recalled: January 7, 2016 Customed Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    LOTS: SL15202 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16
  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:
Customed, Inc
Reason for Recall:
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Product Codes/Lot Numbers:

LOTS: SL15202 (150619129) 30-JUN-16 SL15209 (150619381) 31-JUL-16 SL15215 (150619381) 31-JUL-16 SL15265 (150919830) 30-SEP-16 SL15265 (150920072) 30-SEP-16

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1421-2016

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