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Recall Observatory FDA recall evidence

Device product

Various Port Insertion Packs

Z-1696-2022

June 16, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90574
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1696-2022

Official wording

Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Code information: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) GSPI26E, 2108202, 770211, 44336884-005 2) GSPI26E, 2108202, 770211, 44336909-005

Distribution pattern: Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was exposed to multiple sterilization cycles without validation for multiple exposures.