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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 manometersee related information
Date Initiated by FirmNovember 18, 2005
Date PostedApril 26, 2006
Recall Status1 Terminated 3 on May 07, 2007
Recall NumberZ-0812-06
Recall Event ID 35122
510(K)NumberK904674 
Product Classification Manometer, Blood-Pressure, Venous - Product Code KRK
ProductMX441B, 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
FEI Number 1526863
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
ActionThe 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 Commerce6910 devices
DistributionThe recalled device was distributed to customers throughout the U.S.A. and in Canada.
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.
510(K) Database510(K)s with Product Code = KRK
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