FDA-Device2014-12-10Class I
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed, Inc
Hazard
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Sold states
US Distribution to Florida, New York and Puerto Rico..
Affected count
400
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0398-2015Don't want to check this manually?
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