Recall Z-0787-2018 ยท LRO General Surgery Tray
Avid Medical, Inc.
AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
| Date | Jun 22, 2017 |
| Status | Terminated |
| Reason | Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. |
| Root cause | Nonconforming Material/Component |
| Action | An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be p |
| Quantity | 15 |
| Distribution | Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.