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U.S. Department of Health and Human Services

Class 1 Device Recall ZOOM 71 Reperfusion Catheter

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  Class 1 Device Recall ZOOM 71 Reperfusion Catheter see related information
Date Initiated by Firm August 13, 2021
Date Posted September 29, 2021
Recall Status1 Completed
Recall Number Z-2577-2021
Recall Event ID 88611
510(K)Number K183043  K202182  K210996  
Product Classification Catheter, thrombus retriever - Product Code NRY
Product Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Code Information Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001
Recalling Firm/
Manufacturer		 IMPERATIVE CARE INC
1359 Dell Ave
Campbell CA 95008-6609
For Additional Information Contact Nora Hadding
699-235-8155
Manufacturer Reason
for Recall		 There is a potential for distal end of catheters to fracture and become detached.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 18, 2021 , Imperative Care issued a "Urgent: Voluntary Medical Device Recall" Notification to all affected healthcare facilities. In addition to informing consignees about the recalled product, Imperative Care ask consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific lot numbers listed within the recall notification . 3. Remove and quarantine all unused affected products in your inventory. 4. Return the potentially affected products to Imperative Care. Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary. 5. If replacement product is needed, your Imperative Care Sales Representative can assist you with identifying suitable replacement product. 6. Complete the attached Customer Confirmation Certificate and contact your local Imperative Care Sales Representative. 7. Please ensure that the attached Customer Acknowledgement Certificate is returned within 3 business days to acknowledge receipt within your Department/Facility. This may be a requirement within your healthcare organization. 8. If you have any questions regarding this voluntary recall, please contact Imperative Care Customer Service at 1-408-502-7548, your Imperative Care Sales Representative, or email us at return@imperativecare.com. 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce 3118 units
Distribution US nationwide 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.
510(K) Database 510(K)s with Product Code = NRY and Original Applicant = Imperative Care Inc.
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