| Date Initiated by Firm | January 02, 2026 |
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| Date Posted | February 09, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1338-2026 |
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| Recall Event ID |
98298 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01. |
|---|
| Code Information |
Kit Code: LIFE0080-01. UDI-DI: 10809160314500. Lot Number: 1650056. Expiration Date: 07/24/2028
|
| FEI Number |
1047429
|
Recalling Firm/
Manufacturer |
AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
|
| For Additional Information Contact | Marlene Jones
757-566-3510 |
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Manufacturer Reason
for Recall | Tyvek bag seal issue which may compromise sterility of the kit. |
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FDA Determined
Cause 2 | Equipment maintenance |
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| Action | AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed. |
|---|
| Quantity in Commerce | 1,500 units |
|---|
| Distribution | US Nationwide distribution in the states of New Jersey. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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