The Recall Desk
ModerateFDA (Devices)·Z-1571-2014·Announced 2014-05-21

Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 90 units of the MedStream Programmable Infusion Pump, 20 mL (Product Code: 91-4200). The recall is due to a defect where a small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

The affected pumps are intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. The recall covers units distributed worldwide, including Belgium, Germany, Spain, the United Kingdom, Ireland, Italy, Russia, and Turkey.

Patients and healthcare providers should contact Codman & Shurtleff, Inc. for instructions on how to proceed. The recall is classified as Class II by the FDA.

The recalled product

Product
MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
Manufacturer
Codman & Shurtleff, Inc.
Category
Medical Device — Infusion Pump
Hazard
Affected units
90

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 (20)

  • Serial Numbers: NNBLTL
  • NNBLT5
  • NNBLR9
  • NNBLT2
  • NNBLJP
  • NNBLL2
  • NNBLJR
  • NNBLLH
  • NNBLLJ
  • NNBLLG
  • NNBLT0
  • NNBLT1
  • NNBLL7
  • NNBLTC
  • NNBLTN
  • NNBLTK
  • NPBLZ7
  • NPBLZH
  • NPBLZP
  • NPBLZN

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Codman & Shurtleff, Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Codman & Shurtleff, Inc.

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