MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling two MedStream Programmable Pumps 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 Class I, and the rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
Codman & Shurtleff, Inc. is recalling two units of the MedStream Programmable Pump (20ml, model 91-4200US) due to a defect where drug flow rates may exceed programmed flow rates. The device 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 recall affects specific units with US lot/serial numbers NMBJ7K and NMBJ5C. These devices were distributed worldwide, including nationwide in the United States in the states of New Jersey, North Carolina, Texas, and Florida, as well as in Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxembourg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
Consumers and healthcare providers should contact Codman & Shurtleff, Inc. for instructions on how to proceed with the recall. The source text does not specify the exact actions required or the contact method.
The recalled product
- Product
- MedStream Programmable Pump; 20ml - 91-4200US 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
- 2
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 (2)
- Lot/Serial Number US: NMBJ7K
- NMBJ5C
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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