Neonatal PICC Tray — Class II medical device recall Z-1634-2018
Terminated recall by Vygon U.S.A., reported 2018-05-16, distributed nationwide. Potential friction holes may affect the sterility of the product.
| Recall number | Z-1634-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon U.S.A., Lansdale, PA, United States |
| Recall initiated | 2018-02-28 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2019-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 16,520 products |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 08498840010563 |
| Lot numbers | 17C060D |
Product
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Reason for recall
Potential friction holes may affect the sterility of the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1634-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.