Technical Support

Latex Content

Effective September 28, 1998, the United States Food and Drug Administration requires all medical device manufacturers label products that contain dry natural rubber or natural rubber latex in the product’s Directions for Use. To the best of our knowledge unless otherwise described in this Web site, the product’s packaging and / or directions for use, Nellcor™, Puritan Bennett™, Mallinckrodt™ anesthesiology and Shiley™ tracheostomy products do not contain dry natural rubber or natural rubber latex.

If you have questions about the latex status of a particular product, please consult the product’s directions for use. If you cannot locate the product’s directions for use, please contact a local Covidien sales representative.

The following information will assist customers and distributors to quickly and accurately identify the Covidien respiratory and monitoring products contain latex.

Nellcor™ Anesthesia and Respiratory Products

Covidien ProductComponents Containing Latex
Anesthesia and respiratory circuits Face mask head strap
Latex breathing bags**
Anesthesia and respiratory face masksFace mask head strap
Anesthesia and respiratory kits Face mask head strap
Latex breathing bags**
Temperature products WarmFlo pressure infusors and surgical irrigators The following model of infusors contain latex (hand pump and hand pump tubing &en; HP and HPDC versions only) •AD500HP below serial number 13445 •AD500HPDC below serial number 13100 •AD1000HP below serial number 1-6546 • AD1000HPDC below serial number 1-6446

**This product has latex components, which do not come in direct contact with the patient's skin. There is no known risk associated with this product due to the presence of latex.

Blood Pressure Cuff

Covidien ProductCatalog NumberComponents Containing Latex
Infant reusable blood pressure cuff SCBP-6R Internal cuff bladders
Child / small adult reusable blood pressure cuff SCBP-9R Internal cuff bladders
Adult reusable blood pressure cuff SCBP-12R Internal cuff bladders
Large arm reusable blood pressure cuff SCBP-15R Internal cuff bladders
Thigh reusable blood pressure cuff SCBP-18RInternal cuff bladders

These cuff bladders are enclosed in a Dacron bag that includes a urethane lining barrier, however the hose that extends from the cuff may also contain latex. For blood pressure cuffs shipped after February 1, 1997, the blood pressure cuff hose has been treated to provide an external coating of neoprene over the exposed area to minimize the likelihood of latex containing parts making skin contact. The shipping date of the cuff can be determined by examining the date code on the Dacron flap of the blood pressure cuff. The Dacron flap is normally tucked inside the cuff at the hose insertion point. The Nellcor™ SHBP-10 hose, which interfaces between the monitor and blood pressure cuff, does not contain latex. At present, Covidien has not validated any other vendors' reusable cuffs. Latex free neonatal cuffs are available for use with the N-3100.

Mallinckrodt™ Esophageal Tracheal Airway Double Lumen

Covidien ProductCatalog NumberComponents Containing Latex
Mallinckrodt™ esophageal tracheal airway double lumen 5-18237 5-18241 Pharyngeal cuff

Mallinckrodt™ Endotracheal Tubes

Covidien ProductCatalog NumberComponents Containing Latex
Mallinckrodt™ endotracheal tubes All catalog numbers NONE

Shiley™ Hi-Lo Evac Tracheostomy Tube Cuffed Lanz System and Mallinckrodt™ Hi-Lo Oral/Nasal Tracheal Tube Lanz System

Covidien ProductCatalog NumberComponents Containing Latex
Shiley™ Hi-Lo evac tracheostomy tube cuffed Lanz system All catalog numbers Lanz valve contains a latex balloon inside a PVC balloon
Mallinckrodt™ Hi-Lo oral / nasal tracheal tube Lanz system All catalog numbers Lanz valve contains a latex balloon inside a PVC balloon

Oximetry Sensors

In the past, the adhesive coating of the bandage on the Nellcor™ SpO2 sensors (models I-20, I-20R, N-25 and N-25R), Nellcor™ Infant SpO2 Sensor (model I), Nellcor™ Neonatal-Adult SpO2 Sensor (model N) and Nellcor™ Adult-Neonatal Adhesive Sensor Wrap (model ADH-A/N), may have contained a minute amount of natural latex. This material is the same type used in commercial adhesive bandages. Please see below for current information on these products and other sensors.

In the past, latex-free Nellcor™ SpO2 sensors (models N-25LF and I-20LF) were made to meet customer needs. The letters LF indicated these products to be latex free. As of April 2001, the Nellcor™ SpO2 sensors (models I-20 and N-25) have been standardized and are now labeled as latex free. The letters LF have been removed from the product number to minimize redundancy. The initial lot number for latex free sensor (model I-20) is C29017 and the initial lot number for latex free sensor (model N-25) is C29018.

As of June 2002, the Nellcor™ SpO2 Sensors (models N and I) are latex free. As of January 2002, the Nellcor™ Adult-Neonatal Adhesive Sensor Wrap (model ADH-A/N) is latex free.

Early pouches of the disposable Nellcor™ SpO2 sensor line (models MAXA, MAXAL, MAXP, MAXI, MAXN and MAXR) did not state that the products were latex free; however these sensors have always been and will continue to be latex-free.

Private label NOVAPLUS pulse oximetry sensors (models VN-25 and VI-20) are identical in quality and material to the Nellcor™ SpO2 sensors (models N-25 and I-20). They are also latex free.

Shiley™ Tracheostomy Products


The Shiley tracheostomy tube and accessory products are composed of medical grade plastics that do not contain latex material. All packaging of Shiley tracheostomy products are free of latex.

Covidien ProductCatalog NumberComponents Containing Latex
Shiley™ tracheostomy tube and accessory products All catalog numbers NONE

Ventilator and Respiratory Accessory Products

Covidien ProductCatalog NumberComponents Containing Latex
Test lung 4-000612-00 Contains latex
SPU Filter 4-010793-00 Contains latex
Raindrop Nebulizer with Adult Mask 6-001045-00 Strap only
Raindrop Nebulizer with Pediatric Mask 6-001124-00 Strap only
Test Lung Assembly N-4403019 Contains latex

The following Puritan Bennett™ ventilator systems do not contain latex:

  • Puritan Bennett™ 740 ventilator
  • Puritan Bennett™ 760 ventilator
  • Puritan Bennett™ 840 ventilator
  • Puritan Bennett™ 806 compressor
  • Puritan Bennett™ 7200 ventilator – does not contain latex components that would come in contact with patients or users

Miscellaneous Products – Latex Content Not Yet Determined

The latex content status of the parts listed in the following table has not yet been confirmed. Until the latex content status of these parts is resolved, Covidien suggests that they be assumed to contain latex.

Covidien ProductCatalog NumberStatus
Breathing bag F-503100-00 Inactive part
Breathing bag F-503101-00 Inactive part
Breathing bag F-503102-00 Inactive part
Breathing bag F-503104-00
Breathing bag F-503202-00 Inactive part
Form it mask F-651100-00
Form it mask F-651101-00
Form it mask F-651103-00
Form it mask F-651104-00
Form it mask F-651105-00 Inactive part
Form it mask F-651106-00

Packaging of Nellcor™ Critical Care Products

All packaging of Nellcor™ Critical Care Products are free of latex. The table immediately following this line is a quick reference guide to latex free products.

Covidien ProductCatalog NumberComponents Containing Latex
Airway monitoring adapter All catalog numbers NONE
Basic and specialty endotracheal tubes All catalog numbers - current shipments. NONE
Capno-Flo / Capno-Flo basic resuscitators All catalog numbers NONE
INdGO™ manual resuscitators All catalog numbersNONE
DAR™ filters, HMEs and filter / HMEs All catalog numbers NONE
Nellcor™ colorimetric CO2 detectors PEDICAP PEDICAP 6 EASYCAP II EASYCAP II 6 NONE
Gas sampling lines All catalog numbers NONE
Stylets, suction catheters, ventrol Levin, infant feeding tubes, lavacuators and other accessories All catalog numbers NONE
Shiley™ tracheostomy tubes and accessories All catalog numbers NONE
Thermocouple and Thermistor temperature adapters, monitors and cables All catalog numbers NONE
Thermocouple and Thermistor temperature probes All catalog numbers NONE
WarmFlo warmers FW-538 FW-588 NONE
WarmFlo fluid cassettes FW-100 FW-250 NONE
WarmFlo pressure infusers and irrigation pumps AD500 AD500FW AD1000 AD1000FW AD1500 AD1500FW AD2000 AD2000FW SI1000 SI1000FW SI2000 SI2000FW SI3000 SI3000FW NONE - Please see Nellcor™ anesthesia and respiratory products latex table above, for early versions of the HP and DHPDC infusors that contained latex in the hand pump and hand pump tubing
WarmTouch™ warming blankets and blowers NONE

Customer Inquiries About Latex in Products

For questions about Nellcor™, Puritan Bennett™, Mallinckrodt™, Aequitron™, EdenTec™ or Infrasonics products or versions not listed, please contact:

United States and Canada:

Contact the technical services department

Telephone: 1-800-635-5267, option 3 or 1-925-463-4000, ext. 6300

Fax: 1.925.463.4720

Europe, the Middle East and Africa:

Contact a local Covidien sales representative

Mexico, and Central and South America:

Contact the technical services department

Telephone: +1-925-463-4000, ext. 6300

Fax: 1-925-463-4720

Asia (except Japan) and the Pacific Region:

Mallinckrodt Asia Pacific Pte. Ltd. (office located in Singapore)

Telephone: +65-738-4333

Fax: +65-738-4334

Japan:

Mallinckrodt Japan

Telephone: +81-3.5363-5720

Fax: +81.3.5379.5817

Nellcor™ Puritan Bennett Sleep Products

Please contact technical services

CPAP and Bi-Level Systems

Telephone: 1-800-255-6774, option 3 or 1-760-603-5300

Fax: 1-760-603-6684

For Mallinckrodt™, Liebel-Flarsheim and Shiley™ products, including those from Imaging, Pharmaceuticals, Nuclear Medicine, Critical Care and Mallinckrodt Baker:

Liebel-Flarsheim International Product Support

Liebel-Flarsheim Technical Support

Telephone: 1-800-877-0791 or 1-513-761-2700

Fax: 1-513-948-7226

Please include product model / catalog number, institution name, contact person, facility address, phone and fax numbers, and question(s). International mail, faxes and calls accepted.

Mallinckrodt™ Imaging

Contrast media, guide wires, catheters, inflation/deflation devices, ultrasound contrast injectable media and warmer boxes.

Professional Services

Telephone: 1-888-744-1414, option 2 or 1-314-654-2000

Fax: 1.314.654.8206

Mallinckrodt™ Critical Care

Anesthesiology Products

Contact the technical services department

Telephone: 1-888-744-1414, option 3 or 1-314-654-2000

Fax: 1-314-654-8206

Shiley™ Tracheostomy Products

Contact the technical services department

Telephone: 1-800-635-5267, option 3 or 1-925-463-4000, ext. 6300

Fax: 1-925-463-4720

Mallinckrodt™ Pharmaceutical Dosage Products

Contact professional services

Telephone: 1-888-744-1414, option 2 or 1-314-654-2000

Fax: 1-314-654-8206

Mallinckrodt™ Nuclear Medicine

Radioisotopes, generators and lead buckets (to hold isotopes)

Contact professional services

Telephone: 1-888-744-1414, option 2 or 1-314-654-2000

Fax: 1-314-654-8206