FDA Device recall Z-1691-2013
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump)…
- FDA Device
- Class I
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class I recall of MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump)… by Codman And Shurtleff, citing miscalibrated Fill Level Sensor may affect dosing level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1691-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-07 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
Product
MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Reason
Miscalibrated Fill Level Sensor may affect dosing level
Identifiers
| code_info | All serial numbers |
|---|
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-1691-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.