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ARROW
TELEFLEX INCORPORATED · Model IPN919724 · UDI-DI 10801902190366
LFJ
Prescription
10
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
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, 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 |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2019-03-13 | Medical Components, Inc dba MedComp | Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer. |
| 2015-01-21 | Medical Components, Inc dba MedComp | Drug 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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Get your free API keyRead the docsData 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.