The Food and Drug Administration (FDA) clarifies that only the following affected Lots and Batches of Steelex Sternum Set are being voluntarily recalled by B. Braun Medical Supplies, Inc.:
|PRODUCT DESCRIPTION||AFFECTED LOTS||AFFECTED BATCHES|
Steelex Sternum Set
Product registration number: DVR-4774
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the said affected lots/batches of Steelex Sternum Set.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.
Any suspected adverse reaction experienced from the use of the medical device but not limited to the lots/batches stated above should be reported immediately to FDA.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.