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Electrode Skin Prep Pads
Dynarex Corporation · Model 1508 · UDI-DI 00616784150826
0
510(k) clearances
81
Adverse events
20
Recalls
16
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepa |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepa |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepa |
| 2019-12-23 | Carroll-Baccari, Inc. | Samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection on October 15, 2019 were tested and found to be contaminated with Burkholderia cepa |
| 2019-11-07 | Neuronetrix Solutions, LLC dba Cognision | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia |
| 2019-10-29 | Bio-Signal Group Corp. | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| 2019-10-29 | Bio-Signal Group Corp. | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| 2019-09-05 | Carroll-Baccari, Inc. | Product has the potential to be contaminated with Burholderia cepacia. |
| 2019-09-05 | Carroll-Baccari, Inc. | Product has the potential to be contaminated with Burholderia cepacia. |
| 2016-01-22 | Covidien LLC | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
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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.