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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 Lite see related information
Date Initiated by Firm April 20, 2010
Date Posted May 27, 2010
Recall Status1 Terminated 3 on January 06, 2011
Recall Number Z-1693-2010
Recall Event ID 55529
Product Classification compression wrap - Product Code MDR
Product Juxta-Lite compression wrap Large Short 28cm Length with Separate Small AFW Catalog 23125017
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
Action CircAid 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 Commerce 372 total, all sizes
Distribution Worldwide distribution: USA, Japan, Canada, Netherlands
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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