Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2295-2013 — 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

U.S. FDA — Device Enforcement · United States · 2013-08-13 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2295-2013
Date of alert: 2013-08-13
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Codman & Shurtleff, Inc.
Product category: device
Product type: Devices

Reported risk: Drug flow rates exceeding programmed flow rates.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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