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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Codman & Shurtleff, Inc.
See all →- ModerateCodman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
- HighCodman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
- SevereCodman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
- HighCodman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
- SevereCodman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
Same hazard · excessive drug flow
See all →- CriticalMedStream Refill Kit Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- SevereMedStream Programmable Pump Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- SevereMedStream Refill Kit Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
- CriticalMedStream Refill Kit Recalled for Excessive Drug Flow Rates
FDA (Devices) · 2013-10-09
Similar recalls
- CriticalCodman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor
FDA (Devices) · 2013-07-24
- ModerateCodman MedStream Infusion Pump Recall for Low Battery Alarm Issue
FDA (Devices) · 2014-05-21
- HighCodman Certas Programmable Valves Recalled for Potential Malfunction
FDA (Devices) · 2014-02-05
- HighMedtronic Refill Kits Recalled Due to Occluded Extension Tubing Sets
FDA (Devices) · 2014-05-14
- CriticalMedtronic SynchroMed II Pump Recall for Unintended Drug Delivery
FDA (Devices) · 2013-07-03
- SevereMedtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery
FDA (Devices) · 2013-07-03