| | MedWatch - The FDA Safety Information and Adverse Event Reporting Program | 
| | TOPIC: Intraosseous Products by BD: Recall - Due to Product Issues AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: BD is recalling BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits and BD Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries. For more detailed information about this recall and the affected products, click on the red button "Read Recall" below. BACKGROUND: An intraosseous access is most often used in critically ill patients, including cardiopulmonary arrest and severe shock. RECOMMENDATIONS: - Customers should immediately review their inventory for the catalog and lot numbers listed above. Affected needle kits should be destroyed in compliance with the health care institution's process for disposal. The use of affected intraosseous powered drivers should be paused until a BD representative provides instruction that it is safe for use. BD representatives will be reaching out to customers for inspection and will repair the devices if required.
- BD recommends that customers evaluate their clinical needs and consider obtaining and using an alternative intraosseous product. BD will notify customers when replacement products become available.
- Customers requiring additional assistance or guidance may contact the company.
| | | Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: - Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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