Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
FDA Recall Z-1236-03 · Posted 2003-09-17
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Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Date Initiated2000-10-24
Date Terminated2008-06-06
Product Quantity235
Reason for Recall
Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
Firm Action
A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.
Root Cause
Other
Distribution Pattern
Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.
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.
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