FDA-Device2016-04-20Class II
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK 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
25
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK 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-1493-2016Don't want to check this manually?
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