Recall Z-2295-2013
Codman & Shurtleff, Inc. · initiated August 13, 2013
Class I – dangerous or defective products that could cause serious health problems or death
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 filling and re-filling of the Medstream pump reservoir.
Codes / lots: Lot/Serial Number US: 13B090CT
Reason for recall
Drug flow rates exceeding programmed flow rates.
FDA-determined cause: Use error
Action taken
Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique. Consignees are asked to complete the Field Safety Notice Acknowledgement Form and return it to your local Codman Neuro Sales Representative or fax to: 508-977-6665. Consignees are asked to contact your Codman Neuro representative if they have questions, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to 1-866-491-0974, Option 2.
Details
- Recall number
- Z-2295-2013
- Initiated
- August 13, 2013
- Posted by FDA
- September 30, 2013
- Terminated
- September 11, 2014
- Product code
- LKK – Pump, Infusion, Implanted, Programmable
- Quantity
- 5 units
- Distribution
- Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2293-2013 Class I | MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2294-2013 Class I | MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2296-2013 Class I | MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2297-2013 Class I | MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2298-2013 Class I | MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2299-2013 Class I | MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2300-2013 Class I | MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |