FDA Device recall Z-2297-2013
MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Ba…
- FDA Device
- Class I
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class I recall of MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Ba… by Codman And Shurtleff, citing drug flow rates exceeding programmed flow rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2297-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-08-13 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
Product
MedStream Refill Kit (6 units), EMEA: 91-4290 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.
Reason
Drug flow rates exceeding programmed flow rates.
Identifiers
| code_info | OUS: Per recall strategy |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2297-2013%22
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