Recall Z-0680-2018— Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Name: FDA recall Z-0680-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-24

Class II · Terminated

Class II FDA medical device recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., initiated 2017-07-24, terminated 2019-11-07. It names one FDA 510(k) clearance: K954302. Product: CVC Tray Pediatrics. Product Code: AMS-9335CP-2.. Reason: 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..

Recalling firm: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Terminated: 2019-11-07
Firm location: Dover, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K954302 — VYGON PREMI-CATH - LONG TERM CATHETERVygon Corp.·cleared 1996-06-17

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

CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

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.

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