Peripheral Catheter Insertion Kit
FDA product code OWL · Class II (moderate risk) · 21 CFR 880.5200 · General Hospital
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
0510(k) clearances
0PMA approvals
17recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3255-2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV…The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator.… | Cardinal Health 200, LLC | 08/10/2026Open, Classified |
| Z-2394-2026 Class I | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1910-2026 Class II | Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code:…Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured | Arrow International, LLC | 03/11/2026Open, Classified |
| Z-1219-2026 Class II | LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical…BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the… | LSL Healthcare Inc. | 12/22/2025Open, Classified |
| Z-0948-2023 Class II | Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0942-2023 Class II | Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis…Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0935-2023 Class II | PICC KIT, 10/CS, ACCESS MEDICAL LABELPotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the… | Stradis Healthcare | 12/15/2022Open, Classified |
| Z-0464-2023 Class II | Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile…The Port Access Kits were incorrectly labeled as IV Start Kits on the kit label. The case label was… | Medical Action Industries, Inc. 306 | 10/12/2022Terminated |
| Z-2550-2020 Class III | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter…Convenience kit mislabeled with the incorrect catheter effective length on the device label and the… | Access Scientific LLC | 06/15/2020Terminated |
| Z-1640-2018 Class II | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1639-2018 Class II | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1638-2018 Class II | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1637-2018 Class II | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1636-2018 Class II | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1635-2018 Class II | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1634-2018 Class II | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |
| Z-1633-2018 Class II | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the…Potential friction holes may affect the sterility of the product. | Vygon U.S.A. | 02/28/2018Terminated |