MedStream Refill Kit — Class I medical device recall Z-2295-2013
Terminated recall by Codman & Shurtleff, Inc., reported 2013-10-09, distributed nationwide. Drug flow rates exceeding programmed flow rates.
| Recall number | Z-2295-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codman & Shurtleff, Inc., Raynham, MA, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-09-30 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, EG, ES, GB, GR, IE, IL, IT, PT, RU, SA, SE, SI, TR |
| Quantity | 5 units |
| Serial numbers | 13B090CT |
| Model numbers | 91-4287 |
Product
MedStream Refill Kit, U.S: 91-4287 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 for recall
Drug flow rates exceeding programmed flow rates.
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-2295-2013. 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.