Home / Recalls / Vygon U.S.A. / Z-1115-2019

Z-1115-2019 Class II Terminated

Recalled by Vygon U.S.A. — Lansdale, PA

FDA device recall Z-1115-2019 was initiated by Vygon U.S.A. on Dec 6, 2018 and is designated Class II. Reason for recall: DualStop Caps defect causing leaks in affected product The recall status is terminated (terminated May 12, 2020). Affected quantity: 107700.

Recall details

Product Type: Devices
Report Date: Apr 17, 2019
Initiation Date: Dec 6, 2018
Termination Date: May 12, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 107700

Product description

Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.

Reason for recall

DualStop Caps defect causing leaks in affected product

Distribution pattern

US Nationwide distribution.

Code information

Lot codes: 090718FD 250118FD 081117FD 130218FD 050418FD 020518FD

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1115-2019
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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