Recall archive
3 recalls · page 1 of 1
Reported Dec 20, 2017
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics Inc. (Navilyst Medical Inc.)
Matched: Brand · Reason for recall — Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 22, 2016
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Navilyst Medical, Inc., an AngioDyamics Company
Matched: Brand — PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of…
22 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Navilyst Medical, Inc.
Matched: Brand · Reason for recall — Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.
FDA (openFDA device enforcement)
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