Reported Mar 21, 2018 · Terminated
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during…
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · 87 Venture Dr · Dover, NH · 03820-5914
Is this the product you have?
- Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
- Lot codes and dates
AMS-623T-6 (1506075D1508057D1511030D1604024D1605080D1610017D1706097D1707055D) and AMS-626TGSLF (1601102D1603099D160581D1607019D1610057D1703068D1703069D1704065d1706076D1707031d1707056D)
- Amount recalled
- 21350
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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