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U.S. Department of Health and Human Services

Class 1 Device Recall CERENOVUS

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  Class 1 Device Recall CERENOVUS see related information
Date Initiated by Firm February 02, 2024
Date Posted March 13, 2024
Recall Status1 Open3, Classified
Recall Number Z-1284-2024
Recall Event ID 93955
510(K)Number K192804  
Product Classification Catheter, Percutaneous, Neurovasculature - Product Code QJP
Product CERENOVUS CEREBASE DA Guide Sheath, Part Numbers:
a) GS9080SD;
b) GS9090SD;
c) GS9095SD;
Vascular guide-catheter, single-use
Code Information a) GS9080SD: UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661; b) GS9090SD: UPDATED 4/4/2024 UDI-DI 10886704082293, Lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, 31225738; c) GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656
Recalling Firm/
Manufacturer		 Medos International Sarl
Chemin Blanc 36
Le Locle Switzerland
For Additional Information Contact G¿nter Solms
+41 32 934 8472
Manufacturer Reason
for Recall		 Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
FDA Determined
Cause 2		 Under Investigation by firm
Action Johnson&Johnson MedTech/DePuy Synthes issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 02/02/2024 via letter delivered by FedEx. The notice explained the issue and the risk and requested the affected inventory be quarantined and the notice be disseminated to all appropriate personnel. Further instructions state: "Complete the Business Reply Form (BRF) confirming receipt of this notice and scan and email signed form to OneMD-Field-Actions@its.jnj.com or fax it to (305) 265-6889, Attention Line: Cerebase FA2350411. Please return the BRF even if you do not have product subject to this recall. Follow instructions in the letter and immediately call 1-844-483-3882 to return any inventory of CEREBASE DA Guide Sheath devices subject to this recall. To receive credit reimbursement, customers must return product subject to this recall. Attention Line: Cerebase FA2350411"
Quantity in Commerce 1343 units
Distribution Worldwide distribution.
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.
510(K) Database 510(K)s with Product Code = QJP and Original Applicant = Medos International SARL
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