FDAClass IIJuly 3, 2013

Brand Name: Basal/Bolus Infusor. Indicated for the recall

Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.

Why was Brand Name: Basal/Bolus Infusor. Indicated for the recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Recalling firm
Baxter Healthcare Corp.
Quantity
3,255,096 total
Distribution
Distributed Nationwide and in Puerto Rico.
Recall date
July 3, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls