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Class 1 Device Recall Medtronic Duet External Drainage and Monitoring System, Interlink 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-1162-2024 |
| Recall Event ID |
93919 |
| Product Classification |
External cerebrospinal fluid (CSF) diversion - Product Code PCB
|
| Product |
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, 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:
221482527 00613994445360;
221569956 00763000406004;
221569957 00763000406004;
221614450 00613994445360;
221614451 00613994445360;
221614452 00613994445360;
221687764 00763000406004;
221744157 00763000406004;
221744547 00763000406004;
221795478 00613994445360;
221873430 00763000406004;
221955228 00763000406004;
221955229 00763000406004;
222061753 00763000406004;
222061754 00763000406004;
222082061 00613994445360;
222121358 00613994445360;
222186493 00613994445360;
222186494 00613994445360;
222186495 00613994445360;
222240558 00613994445360;
222240559 00613994445360;
222240560 00613994445360;
222274124 00613994445360;
222274125 00613994445360
222322811 00763000406004;
222322812 00763000406004;
222322813 00763000406004;
222580925 00763000406004;
223564705 00763000624767;
223659557 00763000624767;
223659558 00763000624767;;
223734520 00763000624767;
223778508 00763000624767;
223818450 00763000624767;
223999039 00763000406004;
224032596 00763000406004;
224197127 00763000406004;
224218026 00763000406004;
224218028 00763000406004;
224255795 00763000406004;
224277483 00763000406004;
224302821 00763000406004;
224333656 00613994445360;
224878533 00763000624767;
224918533 00763000406004;
224918534 00763000624767;
224918535 00763000624767;
224918536 00763000624767;
224949836 00763000406004;
224949837 00763000406004;
224973998 00763000624767;
224973999 00763000624767;
224990662 00763000406004;
224990663 00763000624767;
224990848 00763000406004;
224990849 00763000624767;
224990850 00763000624767;
224990867 00763000624767;
224990868 00763000624767;
224990886 00763000624767;
225035261 00763000406004;
225234318 00763000406004;
225279760 00763000406004;
225336442 00613994445360;
225336443 00613994445360;
225375797 00763000406004;
225375798 00763000406004
225419717 00763000406004;
225422438 00763000406004;
225468101 00613994445360;
225558567 00763000406004;
225559817 00763000406004;
225559818 00763000406004
225587869 00763000406004;
225587870 00763000406004;
225749838 00763000406004;
226091713 00763000406004;
226111273 00763000406004;
226242270 00763000624767;
226242271 00763000624767;
226288880 00763000624767;
226335061 00763000406004;
226335062 00763000624767;
226467306 00763000624767;
226490966 00763000624767
226517895 00763000624767;
226517896 00763000624767;
226517900 00763000406004;
226546791 00763000624767;
226546794 00763000624767;
226571112 00763000624767;
226571113 00763000624767;
226650893 00763000624767;
226650894 00763000624767;
226665390 00763000406004;
226665391 00763000406004;
226665392 00763000406004;
226689508 00763000624767;
226711355 00763000406004;
226711356 00763000406004;
226711357 00763000406004;
226738254 00763000406004;
226738255 00763000406004;
226738256 00763000406004;
226738257 00763000406004;
226899374 00613994445360;
227136767 00763000624767;
227136768 00763000624767;
227136769 00763000624767;
227187464 00763000624767;
227187465 00763000624767;
227188106 00763000624767;
227194730 00763000624767;
227289113 00763000406004;
227289114 00763000406004;
227289115 00763000406004 |
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 |
30,711 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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