Recall record at a glance
| Official record | Z-1571-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Codman & Shurtleff, Inc. |
| Report date | May 21, 2014 |
| Recall initiation date | Nov 10, 2015 |
| Quantity | 90 |
| Location | Raynham, MA, United States |
Official product description
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.
Why the product was recalled
A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
Distribution information
Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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