FDA-Device2014-12-10Class I
Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Customed, Inc
Hazard
Customed products are being recalled because of 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
56
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
Pediatric Lap Pack, Catalog number 900-1383 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-0287-2015Don't want to check this manually?
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