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Recall Observatory FDA recall evidence

Device product

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

Z-0678-2018

July 24, 2017

Class II

Product summary

Firm
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Event
Event 78951
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0678-2018

Official wording

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.

Code information: Lot Number: 1705060D

Distribution pattern: U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.