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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Bio-Med Devices, Inc. Issues Nationwide Recall on Bio-Med Patient Tubing Assembly with Adaptor

Contact:
Kenneth Close
203-458-0202

FOR IMMEDIATE RELEASE -- Madison, CT -- December 8, 2004 -- Today, Bio-Med Devices, Inc. of Madison, CT is voluntarily recalling Patient Breathing Circuits with Catalog Numbers: 80011, 80015, 8002A, 8002A-7, 8002A-9, DENTL, 3030-5, 4408 (built between September 22, 2004 and December 2, 2004, as indicated by last six digits of lot number MMDDYY). The device contains a 22mm x 22mm adapter made, and recalled, by Unomedical (of McAllen, TX), who has found a potential blockage problem (in a small percentage of parts of this type) which could contribute to serious or life threatening injury to patient. Our firm has not received any complaints or reports of adverse events.

The product is distributed to hospitals and through distributors nationwide.

Bio-Med has suspended sales until the company is certain that the affected product has been removed from distribution. Distributors and hospitals who have purchased the affected products are urged to return the product to Bio-Med Devices at 170 Fort Path Rd, Madison, CT 06437 for replacement.

Distributors and hospital personnel with questions may contact the company at (203) 458-0202.

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