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U.S. Department of Health and Human Services

Class 1 Device Recall Halyard FISTULA (ON/OFF) ALL IN ONE BAG

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 Class 1 Device Recall Halyard FISTULA (ON/OFF) ALL IN ONE BAGsee related information
Date Initiated by FirmApril 09, 2021
Date PostedJune 04, 2021
Recall Status1 Terminated 3 on July 18, 2022
Recall NumberZ-1786-2021
Recall Event ID 87720
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductFISTULA (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
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
ActionA 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 Commerce160 kits
DistributionDistributed US nationwide to TX, AZ, IL, MS, LA, MO, and TN
Total Product Life CycleTPLC Device Report

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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