CLASS I Device recall · Reported 9 Oct 2013 · FDA Enforcement Report
MedStream Refill Kit, U.S recalled by Codman & Shurtleff
Codman & Shurtleff is recalling MedStream Refill Kit, U.S: 91-4288, distributed nationwide in the US. The recall was initiated on 13 Aug 2013 and the FDA has classified it as Class I.
Recall details
- Recall number
- Z-2298-2013
- FDA event ID
- 65821
- Recalling firm
- Codman & Shurtleff, Raynham, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 Aug 2013
- FDA classified
- 30 Sep 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Aug 2013 | Recall initiated by company | |
| 30 Sep 2013 | Classified by FDA | +48 days |
| 9 Oct 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Drug flow rates exceeding programmed flow rates.
Product as listed by the FDA
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: 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. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
Where it was distributed
Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
Questions about this recall
Is MedStream Refill Kit, U.S: 91-4288 recalled?
Yes. Codman & Shurtleff recalled MedStream Refill Kit, U.S: 91-4288 on 13 Aug 2013. The recall is Class I and its status is Terminated. Recall number Z-2298-2013.
Why was it recalled?
Drug flow rates exceeding programmed flow rates.
Where was it sold?
Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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