MedStream Programmable Infusion Pump — Class I medical device recall Z-1691-2013
Terminated recall by Codman & Shurtleff, Inc., reported 2013-07-24, distributed nationwide. Miscalibrated Fill Level Sensor may affect dosing level
| Recall number | Z-1691-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2013-06-07 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, EG, ES, GB, GR, IE, IT, PT, RU, SA, TR |
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 for recall
Miscalibrated Fill Level Sensor may affect dosing level
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1691-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.