Medical Device Recall: Z-0014-04

FDA Recalls dataset · Firm: GE Medical Systems Information Technologies · Status: Terminated

Recall Action Class: N/A Date Initiated: 2000-11-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-04.

Recall Res Number
Z-0014-04
Recalling Firm / Manufacturer
GE Medical Systems Information Technologies
FEI Number
1030184
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2000-11-16
Date Posted
2003-10-15
Date Terminated
2012-05-03
Product Code
N/A
Event Number
26278
Product Quantity
Total of 481
Product Description Critikon brand Omni-Sat Neonatal, Semi-Disposable Sensor, P/N 009130
Reason for Recall Instructions for use contained incorrect sensor reference.
Action Details A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Distribution Pattern Product was distributed to 69 domestic hospitals nationwide including four military accounts. Also product was distributed 6 accounts in Canada, one in Thailand, one in Chile, one in Japan and one in singapore.
Code Information / Serial Numbers Lot numbers 008 and 005

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