Home › Device types › FKG
Tray, Start/Stop (Including Contents), Dialysis
FDA product code FKG · Class 1 · Gastroenterology, Urology
185
Registered devices
1
Adverse events
11
Recalls
6
510(k) clearances
Devices with this code
Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCMEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMEDLINE — MEDLINE INDUSTRIES, INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONMEDLINE — MEDLINE INDUSTRIES, INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.Medical Action Industries — MEDICAL ACTION INDUSTRIES INC.MEDLINE — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedical Action Industries — MEDICAL ACTION INDUSTRIES INC.Centurion — CENTURION MEDICAL PRODUCTS CORPORATIONCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMEDLINE — MEDLINE INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-08 | Medline Industries, LP | Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. Thes |
| 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 |
| 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 |
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2011-08-15 | Lee Medical International Inc | The firm used alcohol triple swabstick and prep pads manufactured by H & P Industries in the manufacture of their custom dialysis kits. Those swabsticks and pa |
| 2011-03-22 | Lee Medical International Inc | Firm manufactured custom dialysis kits with Povidone Iodine (PVP) Prep Pads which were recalled by H & P industries. Those pads were subsequently recalled due |
| 2010-03-16 | Centurion Medical Products | The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged. |
| 2010-03-16 | Centurion Medical Products | The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged. |
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