Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. |
|---|---|
| Recall Number | Z-1900-2012 |
| Classification | Class I |
| Code Info | product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y. |
| Product Distributed Qty | |
| Reason For Recall | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. |
Event Detail
| Event Id | 61943 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Carefusion 2200 Inc |
| City | McGaw Park |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-29 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates. |
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