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U.S. Department of Health and Human Services

Class 2 Device Recall cvp manometer

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  Class 2 Device Recall cvp manometer see related information
Date Initiated by Firm November 18, 2005
Date Posted April 26, 2006
Recall Status1 Terminated 3 on May 07, 2007
Recall Number Z-0812-06
Recall Event ID 35122
510(K)Number K904674  
Product Classification Manometer, Blood-Pressure, Venous - Product Code KRK
Product MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**medex Dublin, OH 43016 USA**STERILE***MX441B CVP Manometer**Lot#***Latex Free''
Code Information All of the following lot codes are affected: Lot Numbers: 30J030048, 30K150054, 31A030144, 31b120110, 31B355998, 31C190086, 31c260053, 31D300042, 31F80073, 31I240006, 31J220068, 32C250072, 32H050182, 32K050108, 33f030089, 33G210028, 33J270026, 34C01D100, 34G01D063, 35A04D101, 35A31D040, 35C29D125
Recalling Firm/
Manufacturer
Medex Inc
6250 Shier Rings Rd
Dublin OH 43016-1270
For Additional Information Contact
614-889-2200
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(s) telephone the firm and obtain a Return Authorization number in order to return the recalled product.
Quantity in Commerce 6910 devices
Distribution The recalled device was distributed to customers throughout the U.S.A. and in Canada.
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 = KRK and Original Applicant = MEDEX, INC.
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