Home › Device 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
MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Merit® Kit — Merit Medical Systems, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Merit® Kit — Merit Medical Systems, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Clear Sequence — MEDICAL ACTION INDUSTRIES INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Merit® Kit — Merit Medical Systems, Inc.MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.Merit® Kit — Merit Medical Systems, Inc.Merit® Kit — Merit Medical Systems, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCMAHURKAR — Mozarc Medical US LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Medical Action Industries, Inc. 306 | Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal. |
| 2024-09-04 | MEDLINE INDUSTRIES, LP - Northfield | It 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 |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2023-11-15 | MEDLINE INDUSTRIES, LP - Northfield | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irr |
| 2019-08-27 | NxStage 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.
