Home / Recalls / Baxter Healthcare Corp. / Z-1602-2013

Z-1602-2013 Class II Terminated

Recalled by Baxter Healthcare Corp. — Round Lake, IL

FDA device recall Z-1602-2013 was initiated by Baxter Healthcare Corp. on Jun 7, 2013 and is designated Class II. 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… The recall status is terminated (terminated Jun 4, 2014). Affected quantity: 3,255,096 total.

Recall Details

Product Type: Devices
Report Date: Jul 3, 2013
Initiation Date: Jun 7, 2013
Termination Date: Jun 4, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,255,096 total

Product Description

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

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.

Distribution Pattern

Distributed Nationwide and in Puerto Rico.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1602-2013
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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