FDAFDA · Food and drugs·Recall number Z-1606-2013
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Published July 3, 2013 · Recall initiated: June 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Distributed Nationwide and in Puerto Rico.
- Lot
- Product Codes: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106 Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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