Z-1518-2020Class II

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform...

Name: Z-1518-2020 Custom procedure trays containing medical components needed to facilitate patient procedures and to perform...
Creator: Avid Medical, Inc.
Published: 2020-02-18
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2020-02-18 / Terminated / root cause: packaging

FDA source

Avid Medical, Inc. began a recall of Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item... on 2020-02-18. FDA classified it as Class II and gives the reason as "The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1518-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-18
Posted: 2020-03-19
Terminated: 2020-11-23
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
Product code: OGD Custom Anesthesia Tray
Reason for recall: The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.
Root cause tag: packaging
FDA root cause: Other
Action: URGENT MEDICAL DEVICE RECALL NOTICE letters, dated February 18, 2020, were distributed to customers. Letter provides identification of the issue, health risk and action to take. Customers were instructed to take the following required actions: " Review all storage and usage locations and segregate and quarantine any trays with an item code and lot number listed on attached Exhibit A. " Complete and return the enclosed Recall Response Form to Sharon.moll@owens-minor .com. Please respond even if you do not have any trays subject to this recall. " Upon receipt of your completed Recall Response Form, product return instructions will be provided and a RGA will be issued, if you do have trays subject to this recall. " If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Recall Notice . Your assistance is appreciated and necessary to prevent any unintended use of the product. If you have any questions, call Sharon Moll at 757-566-9844.
Quantity in commerce: 400 each
Distribution: US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Product codes and lots: Item Codes: ADVC065-18, ADVC068-21, ADVH078-17, ADVM042-07. Lot Numbers: 1324410, 1344158, 1356561, 1366768, 1372012, 1373518, 1375096, 1377349, 1378072, 1378073, 1379861, 1381271, 1381272. Expiration dates: 05/01/2020-09/30/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1518-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1515-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1516-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1517-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1518-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1519-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1520-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1521-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1522-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19
Z-1523-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-19

Product code OGD

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)