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ARROW

TELEFLEX INCORPORATED · Model IPN921957 · UDI-DI 10801902201482

PND Prescription
1
510(k) clearances
983
Adverse events (2 deaths)
10
Recalls
27
Facilities

Description

Pressure Injectable Two-Lumen Midline

Recalls

DateFirmReason
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2022-09-14ARROW INTERNATIONAL Inc.Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related pr
2020-09-14Becton Dickinson & CompanyKits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-09-14Becton Dickinson & CompanyKits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-03-17Becton Dickinson & CompanyIincorrectly packaged without the required lidocaine as labeled
2019-09-24Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
2019-04-23Arrow International IncLidstock states the incorrect expiration date for the product

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.