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U.S. Department of Health and Human Services

Class 2 Device Recall Juxta Lite

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 Class 2 Device Recall Juxta Litesee related information
Date Initiated by FirmApril 20, 2010
Date PostedMay 27, 2010
Recall Status1 Terminated 3 on January 06, 2011
Recall NumberZ-1688-2010
Recall Event ID 55529
Product Classification compression wrap - Product Code MDR
ProductJuxta-Lite compression wrap Large Full Calf Short 28cm Length with Anklet Catalog 23025117
Code Information All units sold between 2/1/10 and 4/14/10.
Recalling Firm/
Manufacturer		 Circaid Medical Products Inc
9323 Chesapeake Dr Ste B1/B2
San Diego CA 92123
For Additional Information Contact
858-576-3550
Manufacturer Reason
for Recall		Some systems in these lots have Built-In Pressure System lines with the incorrect amount of spacing. Some systems in these lots had I inch space between each line with no tension applied. The system should have 1.25 inches of space. The correct spacing (1.25") is necessary to achieve the measured tension ranges. The incorrect spacing may result in the inability to achieve the correct tension level
FDA Determined
Cause 2		Process control
ActionCircAid Medical Products Important Device Product Recall letter dated Apr 20, 2010 was mailed to consignees describing problem, listing affected product and distribution dates. Customers were instructed to locate and return these Juxta-Lite Systems from stock and notify their customers A Retum Authorization number and contact name was provided. this listing for product returns.
Quantity in Commerce372 total, all sizes
DistributionWorldwide distribution: USA, Japan, Canada, Netherlands
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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