Nationwide Warning/Recall on Hospitak Airway Adapters Expands to other Lots and to Viasys, Dräger, and Unomedical Brand Airway Adapters

Date of Recall

2004-12-02

Recall Details

McAllen, TX -- December 2, 2004 -- Unomedical Inc., of McAllen , Texas , announced today that it was expanding its warning and beginning a recall of airway adapters it distributed in the U.S. and Europe . Several adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation. This could result in serious or life-threatening injury to patients.

In a public alert issued on November 28, the company warned the public that at least two lots of its Hospitak brand 22mm/15mm adapters may have been affected by this problem. Although this product is primarily distributed to medical institutions, some units ma y be distributed for home use. These adapters are used in a wide variety of respiratory applications, for example: extending breathing circuits and attaching reservoir bags. Consumers who have one of these recalled products should stop using it, contact their physicians and contact Unomedical, Inc.

Subsequent investigation by the company indicates that other lots of the product, including airway adaptors used in other medical devices, may have been affected. Some of the affected products have been labeled and sold under the Viasys, Unomedical, and Dräger brand name. The total list of affected products and lot numbers are as follows. The lot number is displayed on the immediate label of the package.

• Hospitak, REF 903-GM, IPPB Circuit Exhalation Valve & Nebulizer Circuit Universal 4" Length with Adapter, Lot numbers 04-35 and 04-36
• Hospitak, REF 903-E, IPPB Ventilator Circuit, Lot Number 04-35
• Hospitak, REF 1011, IPPB Ventilator Circuit, Lot numbers 04-40 and 04-41
• Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10", Lot number 04-38
• Hospitak, REF CJ4N2Y-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12", Lot number 04-37
• Hospitak, REF CJ4N1VY-E, Jackson-Rees, Anesthesia Non-Rebreathing Circuit, 12", Lot number 04-37
• Hospitak, REF 962-E, Adapter 22mm/15mm, Lot numbers 04-37, 04-38, 04-40, 04-41, 04-44,  04-45, 04-46, 04-47 and 04-48
• Hospitak, REF 1450, Face Ten Mask w/ Aerosol Tubing 60", Oxygen Tubing 7' & Connector, Lot numbers 04-42, 04-43, and 04-47
• Hospitak, REF 8026, Adapter 22mm/15mm, Lot numbers 04-36, 04-37, and 04-47
• Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72", Lot numbers 23604005 and 31504003
• Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60", Lot Numbers 31304004
• Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., Lot numbers 27904001 and 29504001
• Viasys, REF BLD-8101, Pulmanex Carhill Valve Kit: Medium Adult, Lot numbers 28004002 and 29604001
• Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, Lot number 29404003
• Unomedical REF 962MM, Adapter 22mm/15mm, Lot numbers 04-35, 04-36, 04-37, and 04-40
• Dräger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, Lot numbers 04-38 and 04-44

Patients and medical health professionals who have Hospitak, Viasys, Unomedical, and/or Dräger brand airway adapters should check with Unomedical, Inc. before using the product. Patients and health care institutions who are not sure of the origin of the airway adapters they have in stock may want to check with their suppliers to make sure that they are not affected by this recall.

To date one serious patient injury has been reported.

Patients and medical institutions may contact Unomedical at 1-800-634-6003. Those who have other questions or concerns may also contact their local FDA office.

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