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Recall Observatory FDA recall evidence

Device product

BUTLER Clear Dip, 12 bottles/case

Z-0720-2022

January 14, 2022

Class II

Product summary

Firm
Sunstar Americas, Inc.
Event
Event 89460
Status
Terminated
Classification
Class II
Quantity
22514 ea
Official record key
device-enforcement:Z-0720-2022

Official wording

Reason: Product lacks premarket clearance.

Code information: SKU 716P (Clear Dip 16oz), Lots: 1) S350LP 2) S350LN 3) T116JA 4) T117JE 5) T187DH 6) T187DJ 7) T263FD

Distribution pattern: United States Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product lacks premarket clearance.