| 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-0527-2024 |
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| Recall Event ID |
93395 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | STERILE STERILE PREP STICK, REF DYNDA1134 |
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| Code Information |
UDI/DI 40888277098023 (case), 10888277098022 (each), Lot numbers: 2023082190
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| 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 | 240 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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