Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0933-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 3, 2017

Date Posted: March 21, 2018

Recall Number: Z-0933-2018

Event ID: 79318

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.

Status: Terminated

Product Quantity: 21350

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.

Voluntary or Mandated:

Voluntary: Firm initiated