Z-2591-2016Class II

Pediatric Kidney Biopsy Tray

Name: Z-2591-2016 Pediatric Kidney Biopsy Tray
Creator: Avid Medical, Inc.
Published: 2015-10-05
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2015-10-05 / Terminated / root cause: manufacturing process

FDA source

Avid Medical, Inc. began a recall of PEDIATRIC KIDNEY BIOPSY TRAY on 2015-10-05. FDA classified it as Class II and gives the reason as "Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex". 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-2591-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-05
Posted: 2016-08-18
Terminated: 2017-01-10
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Pediatric Kidney Biopsy Tray
Product code: LRO General Surgery Tray
Reason for recall: Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 cm) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Quantity in commerce: 20
Distribution: Recalled product was distributed to 2 states: Virginia and Massachusetts.
Product codes and lots: Catalog No. MCVA0091-01 , LOT# 1029428

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2591-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2589-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-18
Z-2590-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-18
Z-2591-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-18
Z-2592-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-18

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)