FDAFDA · Food and drugs·Recall number Z-1571-2014
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.
Published May 21, 2014 · Recall initiated: November 10, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
- Lot
- Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH, NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75, NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5, NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N, NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT, NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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