Home › Device types › KMJ
Lubricant, Patient
FDA product code KMJ · Class 1 · General Hospital
136
Registered devices
68
Adverse events
17
Recalls
49
510(k) clearances
Devices with this code
EnsoETM — Advanced Cooling Therapy, LLCCuraplex — BOUND TREE MEDICAL, LLCSurgilube — HR PHARMACEUTICALS INC.Curaplex — BOUND TREE MEDICAL, LLCEndoGlide+™ — Jianerkang Medical Co., LtdOto-Ease 1/2oz bottle 1 pack — Westone Laboratories, Inc.endoglide+™ — BOSTON SCIENTIFIC CORPORATIONendoglide+™ — BOSTON SCIENTIFIC CORPORATIONEndoscopy Kit - Compliance — Micro-tech UsaDynaLube, Lubricating Jelly Sterile, 4 oz. Tube — Dynarex CorporationCARDINAL HEALTH — Cardinal Health 200, LLCEndoscopy Kit - Basic+ — Micro-tech UsaSurgilube — HR PHARMACEUTICALS INC.HCS — Concordance Healthcare Solutions LLCNixit — MAYER LABORATORIES, INC.EndoGlide+™ — Jianerkang Medical Co., LtdDukal — Dukal LLCHCS — DYAD MEDICAL SOURCING, LLCEZ Lubricating — HR PHARMACEUTICALS INC.AQUAGEL — PARKER LABORATORIES INCMediChoice — OWENS & MINOR DISTRIBUTION, INC.Otoferm® Creme — Dreve Otoplastik GmbHHCS — Concordance Healthcare Solutions LLCAQUAGEL — PARKER LABORATORIES INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2016-12-12 | MEDLINE IND | Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping |
| 2016-05-20 | Amerx Health Care Corp. | Product did not meet specifications for Zinc Acetate (OOS). |
| 2012-07-13 | Westone Laboratories, Inc. | Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product. |
| 2011-03-17 | Eli Lilly and Company | Eli Lilly and Company announced 3/17/2011 that patients should not use the alcohol prep pads made by the Triad Group that are contained in the black starter kit |
| 2011-02-28 | Cardinal Health | The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly. |
| 2011-02-24 | Teleflex Medical | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. |
| 2011-02-24 | Teleflex Medical | The irrigation trays contain alcohol prep pads which are included in the scope of a recall initiated by Triad Group, due to a potential bacterial contamination. |
| 2011-02-07 | DeRoyal Processing Center | Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies. |
| 2011-01-18 | Apogee Medical | This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycle |
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