FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
- Recall number
- Z-1602-2013
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
- Status
- Terminated
- Initiated
- 2013-06-07
- Posted
- 2013-06-27
- Terminated
- 2014-06-04
- Reason
- Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.
- Quantity
- 3,255,096 total
- Distribution
- Distributed Nationwide and in Puerto Rico.
- Lot, serial or model codes
- Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13
- 510(k) numbers
- ["K051253"]
- 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