FDA Device recall Z-0680-2018
CVC Tray Pediatrics
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of CVC Tray Pediatrics by Vygon Mfg Dba Churchill Medical Systems, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0680-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-24 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Vygon Mfg Dba Churchill Medical Systems |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Number: 1706044D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2018%22
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