FDA (Devices) recall action 65821

Codman & Shurtleff, Inc. recalled 8 products on 2013-10-09

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2013-10-09
Critical: 2
Units: 4,116

Why these products were recalled

Drug flow rates exceeding programmed flow rates.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

CriticalFDA (Devices)··2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Refill Kit, U.S (6 units): 91-4288 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
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
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.
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 in
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.
Product
MedStream Refill Kit (1 unit), EMEA: 91-4289 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
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 20ml Pump EMEA 91-4200 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
Category
Distribution
5 states
CriticalFDA (Devices)··2013-10-09
MedStream Refill Kit Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.
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 fillin
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
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.
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
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff is recalling MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml - 91-4201US 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 fil
Category
Distribution
5 states
SevereFDA (Devices)··2013-10-09
Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates
Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.
Product
MedStream Programmable Pump; 40ml Pump EMEA 91-4201 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
Category
Distribution
5 states