Recall Z-0933-2018 ยท LRS I.V. Start Kit
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
| Date | Oct 3, 2017 |
| Status | Terminated |
| 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. |
| 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 pl |
| Quantity | 21350 |
| Distribution | US Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS Churchill Medical Systems, Inc., Aug 25, 1988 |