Sion Biotext Medical Ltd.
SION BIOTEXT MEDICAL LTD · Model 1 · UDI-DI 07290100663288
Description
The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water. The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe. The lubricant is sterilized using gamma radiation.
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 lots received between 0 |
| 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 company. |
| 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 kits for Forteo [teripa |
| 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 cycles for these products |
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 docs