MedStream Refill Kit Recall for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 832 units of MedStream Refill Kits (6 units) under FDA recall number Z-2297-2013. The recall is due to a defect where drug flow rates may exceed the programmed flow rates.
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. The Refill Kits are intended for use in the filling and re-filling of the Medstream pump reservoir.
The affected products were distributed worldwide, including nationwide in the US states of New Jersey, North Carolina, Texas, and Florida, and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK.
The recalled product
- 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
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 832
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- OUS: Per recall strategy
Distribution
Part of a larger recall action
This product is one of 8 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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