Recalls / —
—#98608
Product
Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.
- FDA product code
- MEB — Pump, Infusion, Elastomeric
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K982102
- Affected lot / code info
- product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054
Why it was recalled
Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837.
Recalling firm
- Firm
- Baxter Healthcare Corp. Rt.
- Address
- 120 & Wilson Rd, Round Lake, Illinois 60073
Distribution
- Distribution pattern
- Worldwide Distribution - USA including AL and the countries of Mexico and Spain
Timeline
- Recall initiated
- 2011-03-15
- Posted by FDA
- 2011-05-05
- Terminated
- 2012-03-12
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #98608. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.