Date Initiated by Firm | April 20, 2010 |
Date Posted | May 27, 2010 |
Recall Status1 |
Terminated 3 on January 06, 2011 |
Recall Number | Z-1686-2010 |
Recall Event ID |
55529 |
Product Classification |
compression wrap - Product Code MDR
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Product | Juxta-Lite compression wrap XL Short 28cm Length with Anklet Catalog 23026017 |
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
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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 |
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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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