Home / Recalls / Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. / Z-0678-2018

Z-0678-2018 Class II Terminated

Recalled by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. — Dover, NH

FDA device recall Z-0678-2018 was initiated by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. on Jul 24, 2017 and is designated Class II. 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… The recall status is terminated (terminated Nov 7, 2019).

Recall details

Product Type: Devices
Report Date: Feb 28, 2018
Initiation Date: Jul 24, 2017
Termination Date: Nov 7, 2019
Voluntary/Mandated: Voluntary: Firm initiated

Product description

Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

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.

Distribution pattern

U.S.

Code information

Lot Number: 1705060D

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0678-2018
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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