| | Class 2 Device Recall Medline convenience kits |  |
| Date Initiated by Firm | June 06, 2022 |
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| Create Date | July 27, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1472-2022 |
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| Recall Event ID |
90516 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
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| Product | Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927
Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927 |
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| Code Information |
Lot Code: a. Model Number DYNJ0689093V, Lot Codes: 22DMI666, 21LBI103, 21HBO705, 21JBP781, 21JBQ762, 21FBG532, 21FBG535, b. Model Number DYNJ62927, Lot Numbers: 22BBB412
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - SPT
1170 S Northpoint Blvd
Waukegan IL 60085-6757
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| For Additional Information Contact | Kassandra Cotner
866-775-6072 |
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Manufacturer Reason
for Recall | Kits contain leaking bottles of isopropyl alcohol |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
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| Quantity in Commerce | 477 units |
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| Distribution | US Nationwide distribution. |
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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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