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Recall Observatory FDA recall evidence

Device product

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

Z-0933-2018

October 03, 2017

Class II

Product summary

Firm
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Event
Event 79318
Status
Terminated
Classification
Class II
Quantity
21350
Official record key
device-enforcement:Z-0933-2018

Official wording

Reason: The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

Code information: AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)

Distribution pattern: US Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.