Recall Z-0581-2018 ยท LRO General Surgery Tray
Avid Medical, Inc.
AVID Medical QA Pack AV10654-10
| Date | Jul 3, 2017 |
| Status | Terminated |
| Reason | The swab stick collection device provided in a convenience kit expires prior to the kit expiration date. |
| Root cause | Process control |
| Action | Avid Medical began shipping this product on 05/23/2017. Immediately examine your inventory and quarantine all product subject to this correction. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Correction notice. Please complete the attached Correction Response Form as soon as possible. Attached is a label template for use in the generation of an appropriate warning label for application on all AV |
| Quantity | 330 |
| Distribution | Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.