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Water-Jel
WATER-JEL TECHNOLOGIES, L.L.C. · Model CJ-BULK.00.000 · UDI-DI 00743537001057
1
510(k) clearances
97
Adverse events (20 deaths)
14
Recalls
50
Facilities
Description
Cool Jel unit dose 1728 pcs bulk per case; Cool Jel
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-03-03 | Covidien LLC | Product sterility is compromised due to breach of sterile barrier |
| 2015-03-26 | PhotoMedex, Inc. | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not consistent with the intended uses and limitations identified at the time of the clearan |
| 2015-02-25 | Amerx Health Care Corp. | Nonapproved labeling claims (Sterile) |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-09-26 | Amerx Health Care Corp. | Formulation deviation |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
| 2014-07-11 | Amerx Health Care Corp. | Not approved labeling claims (antimicrobial and autolytic debridement) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.