Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
FDA Recall Z-1602-2013 · Posted 2013-06-27
Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeMEB
Date Initiated2013-06-07
Date Terminated2014-06-04
Product Quantity3,255,096 total
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed Nationwide and in Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.