Home / Recalls / Vygon U.S.A. / Z-1638-2018

Z-1638-2018 Class II Terminated

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

FDA device recall Z-1638-2018 was initiated by Vygon U.S.A. on Feb 28, 2018 and is designated Class II. Reason for recall: Potential friction holes may affect the sterility of the product. The recall status is terminated (terminated Feb 19, 2019). Affected quantity: 16,520 total products.

Recall details

Product Type: Devices
Report Date: May 16, 2018
Initiation Date: Feb 28, 2018
Termination Date: Feb 19, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 16,520 total products

Product description

Maximum Barrier Tray, Product Code: MCITX-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.

Distribution pattern

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Code information

Lot Numbers: 16I025D, 16L026D, 17C014D UDI: 08498840009604

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1638-2018
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.

Other recalls by Vygon U.S.A.

Z-1689-2021 Class II — Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit… (Apr 15, 2021)
Z-1115-2019 Class II — Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002… (Dec 6, 2018)
Z-1114-2019 Class II — Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00… (Dec 6, 2018)
Z-1640-2018 Class II — PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the… (Feb 28, 2018)
Z-1639-2018 Class II — PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the… (Feb 28, 2018)
Z-1635-2018 Class II — Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the… (Feb 28, 2018)
Z-1634-2018 Class II — Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the… (Feb 28, 2018)
Z-1637-2018 Class II — PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of… (Feb 28, 2018)
Z-1636-2018 Class II — Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for… (Feb 28, 2018)
Z-1633-2018 Class II — PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs… (Feb 28, 2018)