Home › Walcott Rx Product Inc › Walcott Rx
Walcott Rx
Walcott Rx Product Inc · Model RX30-8008 · UDI-DI 00841019110010
JOS
Prescription
1
510(k) clearances
798
Adverse events (19 deaths)
9
Recalls
51
Facilities
Description
Tungsten Microdissection Needle 2" (5.1cm), Insulated, Straight
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-18 | Boston Scientific Corporation | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of en |
| 2019-11-18 | Boston Scientific Corporation | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of en |
| 2016-08-29 | ConMed Corporation | CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it cou |
| 2012-09-17 | Boston Scientific Corporation | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Bra |
| 2012-09-17 | Boston Scientific Corporation | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Bra |
| 2008-08-08 | Sterilmed Inc | SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e |
| 2006-08-29 | Olsen Medical | Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for har |
| 2004-09-30 | 3M Company / Medical Division | Improper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection. |
| 2004-06-16 | Rita Medical Systems | Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed. |
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 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.