FDA-Device2015-09-09Class II
LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Customed, Inc
Hazard
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Sold states
Distributed Only in Puerto Rico.
Affected count
30
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical procedures and 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-2686-2015Don't want to check this manually?
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