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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Number | Z-0123-2024 |
| Risk Class | Class 2 |
| Recall Quantity | 1,234,567 |
| Classification Date | 2024-01-21 |
| Recall Link | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148385 |
| Notes/Alerts | TBD |
| Recall Reason | The aso (mpe) assayed in buffer cannot be programmed or calibrated using array calculator 5. |
DEVICE
| Manufacturer | GE Healthcare |
|---|---|
| Model Name | DASH 4000 |
| Model Number | 4000 |
| Part/Item/Catalog/ REF/Product Number | REF1234 |
| Device Description | Device desc here |
| Serial Number(s) | TBD |
| Lot #/Exp Date(s) | TBD |
DOCUMENTATION
| Field Service Notification Doc Title Here |
CUSTOMER/PATIENT ACTIONS
1. Immediately review your inventory for the affected product. a. If the product is used for syringe pumps, destroy all affected product subject to this field action following your institution’s process for destruction. b. If the product is used for manual application, the product can continue to be used per IFU.
2. If the affected product was previously used on a patient, no further actions are needed.
3. If the affected product is currently in use with a syringe pump, replace the syringe with a non-impacted lot. Please note that healthcare facilities and providers should rely on their syringe pump manufacturer’s IFU for the specific syringes that are compatible with their syringe pumps.
4. Share this field action notification with all users of the product within your facility network to ensure they are also aware of this field action.
5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement if product is used on syringe pumps and has been discarded.
6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA 1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
DISTRIBUTOR ACTIONS
1. Immediately review your inventory for the affected product. Destroy all unused product subject to the product advisory following your institution’s process for destruction.
2. Identify all customers within your distribution network that purchased any affected product as defined in this notification.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA 1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
