CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

MedStream Programmable Infusion Pump, Product recalled

Codman & Shurtleff is recalling MedStream Programmable Infusion Pump, Product. The recall was initiated on 10 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z

Quantity recalled34

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1572-2014
FDA event ID: 67921
Recalling firm: Codman & Shurtleff, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2015
FDA classified: 9 May 2014
Reported: 21 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

9 May 2014	Classified by FDA
21 May 2014	Published in enforcement report	+12 days
10 Nov 2015	Recall initiated by company	+538 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.

Where it was distributed

Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

Questions about this recall

Is MedStream Programmable Infusion Pump, Product recalled?

Yes. Codman & Shurtleff recalled MedStream Programmable Infusion Pump, Product on 10 Nov 2015. The recall is Class II and its status is Terminated. Recall number Z-1572-2014.

Why was it recalled?

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

Which lots are affected?

Serial Numbers: NNBLV3, NNBLHF, NNBLK4, NNBLV4, NNBLV6, NPBL9F, NPBL89, NPBL8R, NPBL8T, NPBL9B, NPBL77, NPBL2K, NPBL8V, NPBL9D, NPBL8C, NNBLHH, NNBLHD, NNBLHB, NNBLHJ, NNBLHC, NNBLHG, NNBLV7, NNBLV5, NNBLV0, NNBLWC, NPBL2G, NPBL1F, NPBL1D, NPBL1B, NPBL09, NPBL88, NPBL7R, NPBL2N, NPBL6Z

Where was it sold?

Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Codman & Shurtleff

All 59

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21 Aug 2019Device	CLASS II	Galaxy G3 Mini Microcoil Delivery System Product No: GLM915030 recalled	Codman & Shurtleff	Other	CA
3 Jun 2015Device	CLASS II	Codman 3000 Series Refill Set- Huber needles recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System with Ventricular Catheter recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System (no Ventricular Catheter) recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman Lumbar Drainage Catheter Kit II with EDS recalled	Codman & Shurtleff	Packaging Defects	Nationwide

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide