Z-0680-2018 Class II Terminated
FDA device recall Z-0680-2018 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). Affected quantity: 300 units.
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 Quantity
- 300 units
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.
Distribution pattern
U.S.
Code information
Lot Number: 1706044D
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0680-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026