Z-0933-2018 Class II Terminated
FDA device recall Z-0933-2018 was initiated by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. on Oct 3, 2017 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jan 6, 2020). Affected quantity: 21350.
Recall details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Oct 3, 2017
- Termination Date
- Jan 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21350
Product description
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Reason for recall
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.
Distribution pattern
US Distribution.
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0933-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026