FDA-Device2016-04-20Class II
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 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
1920
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 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-1483-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief