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Terminated

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''

FDA Recall Z-0811-06 · Posted 2006-04-26

Recalling FirmMedex Inc
Recall StatusTerminated
Product CodeGWM
Date Initiated2005-11-18
Date Terminated2008-01-22
Product Quantity2480 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 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 a single direct account customer located in Alabama and to

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K822864INTRACRANIAL PRESSURE MONITORING DEVICEMedex, Inc. · 1982-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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