FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit… recallZ-1786-2021 · Avid Medical, Inc. · initiated Apr 9, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Avid Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Environmental control
What the company is doing
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.
Recall details
- Recall number
- Z-1786-2021
- Status
- Terminated
- Initiated by the company
- Apr 9, 2021
- Posted by the FDA
- Jun 4, 2021
- Recalling firm
- Avid Medical, Inc.
- Quantity
- 160 kits
- Product code
- OEZ
- Distribution
- Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Product description
FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
Code information (models, lots, serial numbers)
Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard VAMK024-03_0003Avid Medical, Inc. · Cardiovascular procedure kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 87720).
- Z-1784-2021 · TerminatedADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
- Z-1785-2021 · TerminatedFISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
- Z-1787-2021 · TerminatedDIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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