| Class 1 Device Recall Halyard FISTULA (ON/OFF) ALL IN ONE BAG | |
Date Initiated by Firm | April 09, 2021 |
Date Posted | June 04, 2021 |
Recall Status1 |
Terminated 3 on July 18, 2022 |
Recall Number | Z-1786-2021 |
Recall Event ID |
87720 |
Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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Product | FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03 |
Code Information |
Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022) |
Recalling Firm/ Manufacturer |
Avid Medical, Inc. 9000 Westmont Dr Toano VA 23168-9351
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Manufacturer 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. |
FDA Determined Cause 2 | 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: 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. |
Quantity in Commerce | 160 kits |
Distribution | Distributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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