Z-1786-2021Class I

FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Name: Z-1786-2021 FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Creator: Avid Medical, Inc.
Published: 2021-04-09
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2021-04-09 / Terminated / root cause: manufacturing process

FDA source

Avid Medical, Inc. began a recall of FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03 on 2021-04-09. FDA classified it as Class I and gives the reason as "Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus...". 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-1786-2021
Classification: Class I
Status: Terminated
Initiated: 2021-04-09
Posted: 2021-06-04
Terminated: 2022-07-18
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to consignees on 04/09/2021 via a email. End-users were notified on 4/13/21. The letter instructs the consignee to immediately examine all inventory locations and discontinue use of all Halyard or AVID branded Procedure Trays subject to the field action. Discard all affected Procedure Trays found in inventory. In addition, if the consignees has further distributed this product, the notice instructs the consignee to please identify their customers and notify them at once of this product correction and requirements. The notification to the consignee's customers may be enhanced by including a copy of this URGENT MEDICAL DEVICE CORRECTION Notice. The consignee is also asked to please complete the attached Field Action Response Form (page 3) immediately, even if they no longer have any of the recalled lot numbers left in inventory. The completed form is to be emailed to: [email protected]. If the facility has identified affected product in the consignee's inventory, the recall coordinator will reach back to their facility and provide the consignee with paperwork for documenting destruction of the recalled product.
Quantity in commerce: 160 kits
Distribution: Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Product codes and lots: Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1784-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04
Z-1785-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04
Z-1786-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04
Z-1787-2021	Class I	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04

Product code OEZ

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)