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''
FDA Recall Z-0812-06 · Posted 2006-04-26
Recalling FirmMedex Inc
Recall StatusTerminated
Product CodeKRK
Date Initiated2005-11-18
Date Terminated2007-05-07
Product Quantity6910 devices
Reason for Recall
The product is labeled as 'Latex Free' , however,one of the components of the finished product may contain latex.
Firm 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.
Root Cause
Other
Distribution Pattern
The recalled device was distributed to customers throughout the U.S.A. and in Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.