Vygon Recalls Pediatric CVC Trays Due to Packaging Adhesive Defect
Vygon is voluntarily recalling 300 units of CVC Tray Pediatrics because packaging adhesive gaps may compromise sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a potential sterility issue caused by packaging defects, with no reported illnesses or injuries.
Plain-English summary
Vygon MFG, Inc., dba Churchill Medical Systems, Inc., is conducting a voluntary recall of 300 units of CVC Tray Pediatrics (Product Code: AMS-9335CP-2, Lot Number: 1706044D). The recall was initiated after the Tyvek supplier notified Vygon of issues with their product, specifically that the Tyvek may not be coated completely, causing gaps in the adhesive used to seal the product packaging.
The potential lack of adhesive may affect the sterility of the product. The affected units were distributed in the U.S. No illnesses or injuries have been reported in the source text.
Healthcare providers and consumers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 1706044D
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
See all →- ModerateVygon Recalls 4Fr CT Midline Catheter Trays Due to Sizing Error
FDA (Devices) · 2019-12-04
- ModerateVygon IV Start Convenience Kits Recalled for Iodine Stability Issues
FDA (Devices) · 2018-03-21
- ModerateVygon Recalls 19Ga Huber Needle Sets Due to Packaging Sterility Concerns
FDA (Devices) · 2018-02-28
- ModerateVoluntary Recall of Nutrisafe 2 Syringes Due to Packaging Adhesive Issues
FDA (Devices) · 2018-02-28
- HighVygon Recalls 3-Way Stopcocks Due to Packaging Sterility Concerns
FDA (Devices) · 2018-02-28
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12