Z-0933-2018Class II

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

Name: Z-0933-2018 Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV...
Creator: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Published: 2017-10-03
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2017-10-03 / Terminated

FDA source

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. began a recall of Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency on 2017-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0933-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Posted: 2018-03-09
Terminated: 2020-01-06
Recalling firm: Vygon Mfg
Product: Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
Product code: LRS I.V. Start Kit
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.
FDA root cause: Under Investigation by firm
Action: Vygon sent an Urgent Medical Device Recall letter dated October 3, 2017. Customers requested to check stock and quarantine affected devices and to complete Recall Acknowledgement and Inventory Return Form. Customers instructed to fax or email the form to Vygon including customer contact info. Vygon will contact the customer and issue a Return Merchandise Authorization Number. Distributors instructed to communicate recall to customers who received affected product and provide them copy of the recall notification. Returned products were received in Lansdale, PA warehouse location and placed into quarantine. For further questions, please call Customer Service at (800) 473-5414.
Quantity in commerce: 21350
Distribution: US Distribution.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0933-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0933-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-09

Product code LRS

K882503Class II30 IV Extension Set W/two Male Luer LocksChurchill Medical Systems, Inc. / cleared 1988-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)