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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
May 13, 1998

PRODUCT
Kendall Healthcare Products brand Modudose, 0.9% Sodium Chloride (saline Solution), single use vial for respiratory therapy, in 1.5, 3, and 5 mL vials. Reorder 5251 - NDC 50738-010-18; Reorder 5257 - NDC 50738-010-19; Reorder PR5251 - NDC 50738-010-18.

Recall #D-120-8.

CODE

All lot numbers.

MANUFACTURER

Kendall Healthcare Products Company, Ocala, Florida.

RECALLED BY

Kendall Healthcare Products, Mansfield, Massachusetts, by press release on April 9, 1998, followed by letter April 10-13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION Nationwide and international.

QUANTITY

Product code numbers #5251 and #5257 - 41,946 cases and 6,851 cases respectively (1000 vials per case); Product code #PR5251 - 216 cases; Product code #0454 - 200 cases distributed.

REASON

Microbial contamination-Ralstonia Pickettii (formerly Bulkholderia Pickettii formerly Pseudomonas Pickettii).

 

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.