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Medical Product Recalls

FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

MedWatch, The FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public. Information is provided on safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

Note: TTUHSC Safety Services publishes this information, as is, from the FDA. Please contact the manufacturer for more information.

1/5/2011There’s a recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:

For additional information see:
http://www.fda.gov/Safety/Recalls/ucm239219.htm?sms_ss=email&at_xt=4d2f7781171cd3af%2C0
Triad Group Recall Information

6/18/10 - Urgent Product Recall - HYLENEX - Recombinant (Hyaluronidase Human Injection) Physician Samples, Lot: 909777
Manufacturer: Baxter Healthcare Corporation. A limited number of vials were observed to contain small, flake-like glass particles. See link for lot numbers and additional information.
6/18/10 - Urgent Product Recall - HYLENEX - Recombinant (Hyaluronidase Human Injection) Physician Samples, Lot: 909777

2/9/09 & 1/14/10 - Bone Cement Characteristics Observed During Preparation
Product: C01A KyphX HV-R Bone Cement; C01B KyphX HV-R Bone Cement with Mixer. Manufacturer: Medronic Spine, LLC. Summary: Complaints of lack of inconsistency or lack of homogeneity during cement preparation. Although risk to patient is low, affected lots should be returned to Medronic Spine. See link for lot numbers and additional information.
12-09-09 Recall Notice for Bone Cement

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