AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
FDA Recall Z-0795-2018 · Posted None
Recalling FirmAvid Medical, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2017-06-22
Date Terminated2018-10-12
Product Quantity46
Reason for Recall
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.
Firm 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 printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited.
" Label Quantity- 1 for each affected tray, plus 1 for each outside carton.
" Contact Name
" Address
" Phone Number
Sales representatives were asked to confirm to [email protected] that your customers were notified.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.