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U.S. Department of Health and Human Services

Class 2 Device Recall ciper

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  Class 2 Device Recall ciper see related information
Date Initiated by Firm November 18, 2005
Date Posted April 26, 2006
Recall Status1 Terminated 3 on January 22, 2008
Recall Number Z-0811-06
Recall Event ID 35119
510(K)Number K822864  
Product Classification Device, Monitoring, Intracranial Pressure - Product Code GWM
Product MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch with a stick-on label that reads in part ,''medex Dublin, OH 43016 USA***STERILE**MX6160R1 ** Custom CIPER**Lot #:**Latex Free***SINGLE USE''
Code Information All Lot codes listed as follows are affected: 30K200116, 31A160060, 31A250027, 31B280077, 31E160051,31H030002, 31I140023, 31J050052,31J250065, 32C070041, 32I050037, 32K250019, 33A300046, 33C170028, 33E290076, 33H220008, 3L170057, 34B16D038, 34B26D062, 34E05D055, 34F09D079, 34H05D023, 34H25D034, 34T17D091,34J14D021, 34L16D040 
Recalling Firm/
Manufacturer		 Medex Inc
6250 Shier Rings Rd
Dublin OH 43016-1270
For Additional Information Contact
614-889-2220
Manufacturer Reason
for Recall		 The product is labeled as 'Latex Free'; however, one of the components of the finished product may contain latex.
FDA Determined
Cause 2		 Other
Action The firm sent a recall letter dated 11/18/2005, via Certified mail to all of their customers. In the letter, the firm requests that the consignee telephone the firm and obtain a Return Authorization number in order to return the recalled product.
Quantity in Commerce 2480 devices
Distribution The recalled device was distributed to a single direct account customer located in Alabama and to
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.
510(K) Database 510(K)s with Product Code = GWM and Original Applicant = MEDEX, INC.
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