Home › Device types › KMJ
Lubricant, Patient
FDA product code KMJ · Class 1 · General Hospital
146
Registered devices
70
Adverse events
17
Recalls
49
510(k) clearances
Devices with this code
Endo-Ease Lubricant — SPIRUS MEDICAL LLCHR Lubricating Jelly — HR PHARMACEUTICALS INC.EZ Lubricating — HR PHARMACEUTICALS INC.PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC.PremierPro — PRESTIGE AMERITECH, LTD.AQUAGEL — PARKER LABORATORIES INCendoglide+™ — BOSTON SCIENTIFIC CORPORATIONCuraplex — BOUND TREE MEDICAL, LLCEndoGlide+™ — Jianerkang Medical Co., LtdHCS — DYAD MEDICAL SOURCING, LLCDynaLube, Lubricating Jelly, Sterile, 2 oz. Tube — Dynarex CorporationOto-Ease Single Dose - 100/pk — Westone Laboratories, Inc.Oto-Ease 1/2-oz bottles 5/pk — Westone Laboratories, Inc.PremierPro — PRESTIGE AMERITECH, LTD.HR Lubricating Jelly 2X — HR PHARMACEUTICALS INC.Meijer Vaginal Moisturizer Personal Lubricant — MEIJER, INC.Regard™ — Resource Optimization & Innovation, L.L.C.Regard™ — Resource Optimization & Innovation, L.L.C.Medical Lubricant Jelly — Yangzhou Fartley Medical Instrument Technology Co., LtdEZ — Athena Medical Products Inc.PDI® Lubricating Jelly II — PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.ARROW — TELEFLEX INCORPORATEDEsoCool — Nuvaira, Inc.Nixit — MAYER 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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