FDA Device Intelligence
HomeDevice types › PEV

Dialysis Administration Kit

FDA product code PEV · Class 2 · Gastroenterology, Urology

124
Registered devices
0
Adverse events
6
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-05-21Medical Action Industries, Inc. 306Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
2024-09-04MEDLINE INDUSTRIES, LP - NorthfieldIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr
2019-08-27NxStage Medical, Inc.There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Lite

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.