Recalls / —

—#161426

Product

AVID Medical QA Pack AV10654-10

FDA product code

LRO — General Surgery Tray

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)

Why it was recalled

The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.

Root cause (FDA determination)

Process control

Action the firm took

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 AV10654-10 inventory of impacted lot 1235229. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user location information request to sharon.moll@owens-minor.com. Replacement component swab stick collection systems are available upon request. This correction will be executed with oversight of the associated account sales rep. Please complete and return the enclosed response form as soon as possible.

Recalling firm

Firm

Avid Medical, Inc.

Address

9000 Westmont Dr, Toano, Virginia 23168-9351

Distribution

Distribution pattern

Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.

Timeline

Recall initiated

2017-07-03

Terminated

2018-04-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #161426. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.