🔍 RecallPedia

Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 3, 2014 Codman & Shurtleff Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: CLPCM9, CMBBB2, CMBBB3, CMDBHD, CMDCN7, CMDDJT, CMFBNK, CMFBNL, CMNBZG, CNDCP3, CNGBK5, CNHCZP, CNJB1F, CNJC4R, CNJCMP, CNKBOY, CNLCLO, CNMCYY, CNMDNJ, CNNDHO, CNPBRK, CNPCLW, CPBBGR, CPCCBC, CPCCML, CPDCC2
  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:
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
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 - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 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.

Product Codes/Lot Numbers:

Lot Numbers: CLPCM9, CMBBB2, CMBBB3, CMDBHD, CMDCN7, CMDDJT, CMFBNK, CMFBNL, CMNBZG, CNDCP3, CNGBK5, CNHCZP, CNJB1F, CNJC4R, CNJCMP, CNKBOY, CNLCLO, CNMCYY, CNMDNJ, CNNDHO, CNPBRK, CNPCLW, CPBBGR, CPCCBC, CPCCML, CPDCC2

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2187-2014

Related Recalls

Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated

Codman & Shurtleff

Class I - Dangerous

tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

Sep 15, 2014 Surgical Instruments Nationwide View Details →