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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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: QualityAssurance@owens-minor.com. 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.