The Recall Desk
HighFDA (Devices)·Z-1606-2013·Announced 2013-07-03

Baxter Recalls Basal/Bolus Infusors Due to Rupture Complaints

Baxter Healthcare is recalling 3.2 million Basal/Bolus Infusors due to increased rupture complaints. The devices are used for intravenous medication administration.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (rupture) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Baxter Healthcare Corporation is issuing an urgent product recall for its Basal/Bolus Infusors. These medical devices are indicated for the intravenous administration of medications. The recall involves 3,255,096 units distributed nationwide and in Puerto Rico.

The recall was initiated due to an increase in rupture complaints. Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have since decreased. The company is conducting this recall to ensure that no affected product remains in the field.

Healthcare facilities and consumers should stop using the affected devices and contact Baxter for further instructions. Specific product codes, lot codes, and expiration dates are listed in the official recall notice.

The recalled product

Product
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Infusion Pump
Hazard
Affected units
3,255,096

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product Codes: 2C1955KJP
  • 12/31/14
  • 12/31/15
  • 06/30/14

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 7 recalled by Baxter Healthcare Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Baxter Healthcare Corp.

See all →

Same hazard · rupture

See all →