3-Way Standardbore Stopcock. Product Code: AMS-100.
FDA Recall Z-0682-2018 · Posted None
Recalling FirmVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2017-07-24
Date Terminated2019-11-07
Product Quantity200 units
Reason for Recall
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being
initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the
Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging.
This potential lack of adhesive may affect the sterility of the product.
Firm Action
Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.