Recall Z-0933-2018— Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Name: FDA recall Z-0933-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-03

Class II · Terminated

Class II FDA medical device recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., initiated 2017-10-03, terminated 2020-01-06. It names one FDA 510(k) clearance: K882503. Product: Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.. 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..

Recalling firm: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-03
Terminated: 2020-01-06
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K882503 — 30 IV EXTENSION SET W/TWO MALE LUER LOCKSChurchill Medical Systems, Inc.·cleared 1988-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.