Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
FDA Recall Z-2146-2023 · Posted 2023-07-14
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Recalling FirmAesculap Implant Systems LLC
Recall StatusOpen, Classified
Product CodeHXK
Date Initiated2023-05-18
Product Quantity7 units
Reason for Recall
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Firm 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 [email protected] 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.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution in the states of DC, MO, PA, TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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