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Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, |
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| Date Initiated by Firm |
January 22, 2024 |
| Date Posted |
February 27, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1163-2024 |
| Recall Event ID |
93919 |
| Product Classification |
External cerebrospinal fluid (CSF) diversion - Product Code PCB
|
| Product |
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a
means to reduce intracranial pressure and CSF volume. |
| Code Information |
Lot Number/GTIN:
221482529 00763000395971;
221520718 00763000395971;
221648854 00763000395971;
221687765 00763000395971;
221744158 00763000395971;
221744549 00763000395971;
221795479 00613994445377;
221827827 00613994445377;
221827828 00613994445377;
221873427 00763000395971;
221873428 00763000395971;
221915124 00763000395971;
221915125 00763000395971;
221916163 00613994445377;
221916164 00763000395971;
221955230 00763000395971;
221955231 00763000395971;
222015665 00613994445377;
222061755 00613994445377;
222204094 00613994445377;
222345104 00613994445377;
222345105 00613994445377;
222346067 00613994445377;
222393929 00763000395971;
222393930 00763000395971;
222530273 00613994445377;
222543362 00763000395971;
222543363 00763000395971;
222580924 00613994445377;
222970856 00613994445377;
222970857 00613994445377;
222970858 00613994445377;
222999295 00613994445377;
222999296 00613994445377;
223070846 00763000395971;
223130156 00763000395971;
223165960 00763000395971;
223165961 00763000395971;
223165962 00763000395971;
223251949 00763000395971;
223580360 00763000624774;
223620063 00763000624774;
223621055 00763000624774;
223659559 00763000624774;
223659560 00763000624774;
223698571 00763000624774;
223734521 00763000624774;
223734522 00763000624774;
223778509 00763000624774;
223999041 00613994445377;
224032597 00763000624774;
224173197 00763000395971;
224342656 00763000395971;
224387139 00763000395971;
224852792 00763000624774;
224852793 00763000624774;
224852794 00763000624774;
224877792 00763000624774;
224878534 00763000624774;
224878535 00763000624774;
224918537 00763000624774;
224949833 00613994445377;
224990656 00763000624774;
224990658 00613994445377;
224990659 00613994445377;
224990661 00613994445377;
224990664 00763000624774;
224990665 00763000624774;
224990851 00763000624774;
224990869 00763000624774;
224990887 00763000624774;
224990888 00763000624774;
225035347 00763000624774;
225234319 00763000395971;
225279761 00763000395971;
225422433 00763000624774;
225468089 00763000395971;
225500028 00763000395971;
225558568 00613994445377;
225587871 00763000395971;
225587872 00763000395971;
225587873 00763000624774;
225587874 00763000624774;
225749839 00763000395971;
225749840 00763000624774;
226111272 00763000395971;
226242266 00763000624774;
226242267 00763000624774;
226242268 00763000624774;
226242269 00763000624774;
226288881 00763000624774;
226288882 00763000624774;
226335063 00763000624774;
226335064 00763000624774;
226335065 00763000624774;
226366037 00613994445377;
226420630 00613994445377;
226420631 00763000395971;
226420632 00763000624774;
226490978 00613994445377;
226490979 00613994445377;
226517897 00763000624774;
226517898 00763000624774;
226567488 00763000624774;
226567489 00763000624774;
226567490 00763000624774;
226567492 00763000624774;
226616244 00763000624774;
226616246 00763000395971;
226756270 00763000395971;
226756271 00763000624774;
226756272 00763000624774;
226810274 00763000624774;
226899370 00763000395971;
226899372 00763000624774;
226951461 00763000395971;
226951462 00763000395971;
226951463 00763000624774;
226951464 00763000624774;
227006497 00763000624774;
227007687 00763000624774;
227136770 00763000624774;
227188107 00763000624774;
227289116 00763000395971;
227289117 00763000395971;
227307929 00763000624774;
227387373 00763000624774;
|
Recalling Firm/
Manufacturer |
Medtronic Neurosurgery
5290 California Ave
Irvine CA 92617-3073
|
Manufacturer Reason
for Recall |
Potential for catheter disconnection
from the patient line stopcock connectors.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
On January 23, 2024, Medtronic CSF issued a "URGENT: MEDICAL DEVICE RECALL" Notification to affected consignees via mail. Medtronic CSF asked consignees to take the following actions:
1. Immediately identify and quarantine any unused impacted product(s).
2. Return all unused and non-expired product(s) in your inventory to Medtronic. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable.
3. Work with your Medtronic Rep to receive an RGA# or contact us at 1-800-874-5797, Option 1, to coordinate inventory replacement/credit. Reference FA1400, Lot Number, and Product Number.
4. Reference the RGA# in the attention line when returning the affected product. Credit for products returned without an RGA# may be delayed.
5. Return unopened affected units to: Medtronic, Attention: [Insert RGA #], 4340 Swinnea Rd., Building B, Returns cage, Memphis, TN 38118
6. Complete and return the Customer Confirmation Form, even if you do not have any unused affected product to return via email to neuro.quality@medtronic.com within 30 days of receipt.
If you have any questions regarding this communication, please contact your Medtronic representative. |
| Quantity in Commerce |
32,404 units |
| Distribution |
Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of Ireland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
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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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