FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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.
- Recall number
- Z-2146-2011
- Recalling firm
- Baxter Healthcare Corp.
- 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.
- Status
- Terminated
- Initiated
- 2011-03-15
- Posted
- 2011-05-05
- Terminated
- 2012-03-12
- Reason
- 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
- Labeling mix-ups
- Action
- 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.
- Quantity
- 3,696 units
- Distribution
- Worldwide Distribution - USA including AL and the countries of Mexico and Spain
- Lot, serial or model codes
- product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054
- 510(k) numbers
- ["K982102"]
- PMA numbers
- not on file
- Product code
- MEB
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28