Company: Baxter Healthcare Corp
Date of Enforcement Report: 7/31/02
Class: II
PRODUCT
Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2.
REASON
Software anomaly allows access to change prescription or program bolus without security.
CODE
Product codes 2L3107 and 2L3107R, all serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 10, 2002.
Manufacturer: Baxter Healthcare Pte. Ltd., Singapore, SG. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9,927 pumps.
DISTRIBUTION
Nationwide.
