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ARROW

TELEFLEX INCORPORATED · Model IPN030088 · UDI-DI 20801902001126

LFJ Prescription
1
510(k) clearances
2,170
Adverse events (140 deaths)
6
Recalls
23
Facilities

Description

Two-Lumen Hemodialysis Catheterization Set with Blue FlexTip(R) Catheter for High Volume Infusions

Recalls

DateFirmReason
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
2019-03-13Medical Components, Inc dba MedCompTray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
2019-03-13Medical Components, Inc dba MedCompTray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
2019-03-13Medical Components, Inc dba MedCompTray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
2019-03-13Medical Components, Inc dba MedCompTray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
2015-01-21Medical Components, Inc dba MedCompDrug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule

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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.