🔍 RecallPedia

Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.

Class I - Dangerous
🏥 Medical Devices Recalled: May 16, 2013 Codman & Shurtleff Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Codes: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL
  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:
Codman & Shurtleff, Inc.
Reason for Recall:
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.

Product Codes/Lot Numbers:

Lot Codes: CLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0864-2014

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Class I - Dangerous

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