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January 2017 MedSun Newsletter
Recalls and Safety Alerts:
Patient Safety Alert: Contaminated Organ Preservation Solution
The CDC, Healthcare Resources and Services Administration (HRSA), FDA, and Iowa Department of Public Health (IDPH) are investigating a report of bacterial contamination of the organ preservation solution SPS-1, manufactured by Organ Recovery Systems (ORS). Do not use SPS-1 from the following lots: PBR-0074-330, expiration 07/01/2018 and PBR-0060-392, expiration 06/01/2018...
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall
The Standard Offset Cup Impactors are reusable handheld devices used during hip joint replacement surgeries to implant cups in the hip socket (acetabulum). Greatbatch Medical is recalling the Standard Offset Cup Impactor with a POM-C handle that failed sterility testing when sterilized in a dedicated instrument case. Non-sterile surgical devices can lead to infections, and other serious adverse health consequences...
FDA Bans Powdered Surgeon Gloves, Powdered Patient Examination Gloves and Absorbable Powder for Surgeon’s Gloves
FDA displayed the final rule to ban powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove because these products present unreasonable and substantial risk to health care providers, patients and other individuals. The act of banning a device is an important decision, and the FDA only takes this action on rare occasions when necessary to protect the health of the public...
Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall
Centurion is recalling the Centurion Convenience Kits containing Multi-Med Single Lumen Catheters. The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process. If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences...
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