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U.S. Department of Health and Human Services

Class 2 Device Recall ECONO STERILE

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 Class 2 Device Recall ECONO STERILEsee related information
Date Initiated by FirmDecember 03, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0937-2025
Recall Event ID 95946
Product Classification Handle, scalpel - Product Code GDZ
ProductECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Code Information 96-3500M, UDI/DI 50649111149960, Lot codes: SK-125
FEI Number 2523865
Recalling Firm/
Manufacturer		 Sklar Instruments
1333 Lenape Rd
West Chester PA 19382-6816
For Additional Information ContactDouglas B. Kraemer
610-430-3200 Ext. 217
Manufacturer Reason
for Recall		Reports of various packaging issues that may result in a breach of the sterile barrier.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to surgi@sklarcorp.com. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.
Quantity in Commerce150 units
DistributionDomestic: Nationwide Distribution
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 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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