Reported Oct 9, 2013 · Terminated
MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the…
Codman & Shurtleff, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Codman & Shurtleff, Inc. · 325 Paramount Drive · Raynham, MA · 02767
Is this the product you have?
- MedStream Refill Kit, U
- S (6 units)91-4288
- Product UsageThe 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
- Amount recalled
- 0 - product used for internal training purposes only
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Stop using this product now
Drug flow rates exceeding programmed flow rates.
Using this product could cause serious injury, illness or death — stop using it now.
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