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U.S. Department of Health and Human Services

Class 2 Device Recall Heparin Needle

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  Class 2 Device Recall Heparin Needle see related information
Date Initiated by Firm May 18, 2023
Date Posted July 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-2146-2023
Recall Event ID 92575
Product Classification Holder, needle; Orthopedic - Product Code HXK
Product Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable
Article Number: MD610
Code Information GUIDID: 04046963469054 Lot Number: 22002834
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact SAME
800-258-1946
Manufacturer Reason
for Recall		 Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
FDA Determined
Cause 2		 Labeling Change Control
Action Aesculap Inc, a B. Braun company issued Urgent Medical Device Recall Notification Letter dated 5/18/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Determine your current inventory of the affected product within your facility. (See for instructions in identifying impacted devices.) 3. Cease use and quarantine product subject to recall. 4. Utilizing the attached "Product Recall Acknowledgement Form", record the total number of individual impacted pieces. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Recall Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to PA OualityAssurance.BBMUS Service@bbraunusa.com or faxing the form to (610) 849-1197 within two weeks of receipt, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your acknowledgement form, a customer support representative will contact you with instructions on how to return any impacted pieces in your possession. Complete the acknowledgment form. Included with letter Instructions for Identifying Affected MD610 etched as MD611.
Quantity in Commerce 7 units
Distribution US Nationwide distribution in the states of DC, MO, PA, TX.
Total Product Life Cycle TPLC 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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