Needle System Recall: Civco Medical Instruments eTRAX Kit 12G (Aurora)
FDA recalls Civco Medical Instruments' eTRAX Starter Kit 12G (Aurora) due to an error in needle sensor inspection and programming. This could cause the needle tip position to be incorrectly identified on the user interface. Two units were distributed in OH, PA, WA, and China; recall numbers UDI-DI 00841436111034 and Lot A228672.
| Brand | Civco Medical Instruments Co. Inc. |
|---|---|
| Product | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 |
| Reason | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. |
| Severity | moderate |
| Units affected | 20 |
| Distribution | US States: OH, PA, WA. China. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the recalled kit immediately.
- Contact Civco Medical Instruments for instructions on return, replacement, or remedy.
- Check if your unit matches UDI-DI 00841436111034 or Lot A228672 and follow any given instructions.
- Monitor FDA updates for additional recall guidance.
How to identify the recalled item
| Lot / date codes | UDI-DI: 00841436111034; Lot Number: A228672 |
|---|---|
| Lot / date codes | UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.