—#161478

Product

AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 QualityAssurance@owens-minor.com that your customers were notified.

Recalling firm

Firm: Avid Medical, Inc.
Address: 9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern: Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

Timeline

Recall initiated: 2017-06-22
Terminated: 2018-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161478. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.