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SafetyAlerts
October 21, 2001

Island Supply Welding Recalls Compressed Oxygen

Norfolk, NE (SafetyAlerts) - The Food and Drug Administration (FDA) said that Island Supply Welding Co is recalling Oxygen, USP, Compressed, in cylinder sizes of E, D, M6, M9, and M12, Rx only Recall.

This is the first public notice of this Class lI recall issued by the FDA.

PRODUCT
Oxygen, USP, Compressed, in cylinder sizes of E, D, M6, M9, and M12, Rx only Recall # D-036-2.

CODE
Cylinders filled on 8/10/01, 8/11/01, 8/13/01, and 8/14/01.

Lot numbers are:
2-H-10-V-1 - Size E, D, and M6;
2-H-10-V-2 - Size E and M6;
2-H-10-V-3 - Size E, D, and M6;
2-H-10-V-4 - Size M6;
2-H-11-V-1 - Size E;
2-H-13-V-1 - Size E;
2-H-13-V-2 - Size E and D;
2-H-13-V-4 - Size E, D, M12, M9, and M6;
2-H-14-V-1 - Size E.

RECALLING FIRM/ MANUFACTURER
Island Supply Welding Co. Norfolk, NE, by phone on 10/18/01.

REASON
CGMP Deviations, including but not limited to improper cleaning, and filling of high pressure cylinders and calibration of assay equipment.

PRODUCT
Size E - 100 or 101 (firm is checking to determine the discrepancy); Size D - 26; Size M12 - 2; Size M9 - 1; Size M6 - 59.

DISTRIBUTION
NE
.

 
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During 2000 there were over
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.