| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | November 03, 2023 |
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| Date Posted | December 11, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0528-2024 |
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| Recall Event ID |
93395 |
| Product Classification |
General surgery tray - Product Code LRO
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| Product | STERILE PVP, REF DYNDA1649 |
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| Code Information |
UDI/DI 40889942326519 (case), 10889942326518 (each), Lot numbers: 2022060190, 2022021590
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
886-359-1704 |
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Manufacturer Reason
for Recall | The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers. |
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| Quantity in Commerce | 700 units |
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| Distribution | US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
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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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