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U.S. Department of Health and Human Services

Class 2 Device Recall Arjo Disposable INTRAOPERATIVE PROBE

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  Class 2 Device Recall Arjo Disposable INTRAOPERATIVE PROBE see related information
Date Initiated by Firm February 11, 2022
Create Date April 20, 2022
Recall Status1 Completed
Recall Number Z-0960-2022
Recall Event ID 89580
510(K)Number K201425  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Code Information Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Recalling Firm/
Manufacturer		 Huntleigh Healthcare Ltd.
35 Portmanmoor Road
Cardiff United Kingdom
For Additional Information Contact
44292048-5885
Manufacturer Reason
for Recall		 Faceplate may become detached from the probe body.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes.
Quantity in Commerce 150 devices
Distribution US Nationwide distribution in the states of OK, CA, GA, MI, VA.
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 = ITX and Original Applicant = Huntleigh Healthcare Limited
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