FDA-Device2016-04-20Class II
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
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
60
Manufactured in
Calle Igualdad Final #7, N/A, Fajardo, PR, United States
Products
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1401-2016Don't want to check this manually?
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