Z-0581-2018Class II

AVID Medical QA Pack AV10654-10

Name: Z-0581-2018 AVID Medical QA Pack AV10654-10
Creator: Avid Medical, Inc.
Published: 2017-07-03
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2017-07-03 / Terminated / root cause: manufacturing process

FDA source

Avid Medical, Inc. began a recall of AVID Medical QA Pack AV10654-10 on 2017-07-03. FDA classified it as Class II and gives the reason as "The swab stick collection device provided in a convenience kit expires prior to the kit expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0581-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-03
Posted: 2018-02-09
Terminated: 2018-04-17
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: AVID Medical QA Pack AV10654-10
Product code: LRO General Surgery Tray
Reason for recall: The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
Root cause tag: manufacturing process
FDA 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 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 [email protected]. 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.
Quantity in commerce: 330
Distribution: Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)