The Recall Desk
HighFDA (Devices)·Z-1605-2013·Announced 2013-07-03

Baxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints

Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in 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 is classified as FDA Class II, which typically corresponds to a High severity score (3) when no hospitalizations or serious injuries are explicitly reported in the source text.

Plain-English summary

Baxter Healthcare Corporation is issuing an urgent product recall for SV Elastomeric Infusion Devices. These devices are indicated for the intravenous administration of medications. The recall is being conducted due to an increase in complaints regarding product rupture.

The affected products were distributed nationwide and in Puerto Rico. Baxter has implemented product and process improvements that have substantially improved product quality, and complaint rates for ruptures have decreased since these changes. The company is conducting this recall to ensure that no affected product remains in the field.

Healthcare providers and consumers should check their inventory for the specific product codes and lot codes listed in the official recall notice. If you have these devices, you should stop using them and contact Baxter Healthcare for instructions on how to return or dispose of the product.

The recalled product

Product
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Manufacturer
Baxter Healthcare Corp.
Category
Medical Device — Infusion Devices
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 (7)

  • Product Codes: 2C1071KJP
  • 2C1073KJP
  • 12/31/13
  • 12/31/14
  • 06/30/14
  • 06/30/15
  • 12/31/15

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 · product rupture

See all →