Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Class I - DangerousWhat Should You Do?
- Check if you have this product: LOTS: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-16
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT 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: SL15170 (150619116) 30-JUN-16 SL15175 (150619116) 30-JUN-16 SV15168 (150518601) 30-JUN-16 SV15168 (150318049) 30-JUN-16 SL15199 (150719623) 31-JUL-16 SL15224 (150719623) 31-JUL-16 SL15225 (150820150) 31-AUG-16 SL15264 (150920928) 30-SEP-16 SL15264 (150920679) 30-SEP-16 SL15268 (150920928) 30-SEP-16
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1411-2016
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.