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Recall Observatory FDA recall evidence

Device product

Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.

Z-1602-2013

June 07, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 65365
Status
Terminated
Classification
Class II
Quantity
3,255,096 total
Official record key
device-enforcement:Z-1602-2013

Official wording

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.

Code information: 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

Distribution pattern: Distributed Nationwide and in Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.