Class 2 Device Recall MedStream Programmable Infusion Pump

• Date Initiated by Firm: November 10, 2015
• Date Posted: May 09, 2014
• Recall Status: Terminated on November 10, 2015
• Recall Number: Z-1571-2014
• Recall Event ID: 67921
• PMA Number: P890055
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200; ; 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.
• Code Information: Serial Numbers: NNBLTL, NNBLT5, NNBLR9, NNBLT2, NNBLJP, NNBLL2, NNBLJR, NNBLLH, NNBLLJ, NNBLLG, NNBLT0, NNBLT1, NNBLL7, NNBLTC, NNBLTN, NNBLTK, NPBLZ7, NPBLZH, NPBLZP, NPBLZN, NPBLZM, NPBLZK, NPBLZ4, NPBLZJ, NPBLY3, NPBLY5, NPBLY4, NPBLY7, NPBLZT, NPBLY9, NPBLZR, NPBL7M, NPBL74, NPBMFN, NPBMF0, NPBMHJ, NPBMHK, NPBL71 NPBL9H, NNBLLP, NNBLLN, NNBLLC, NNBLLD, NNBLL3, NPBL0F, NNBLTH, NPBL6N, NPBL6M, NPBL6L, NPBL1T, NPBL17, NPBL1Y, NPBL1W, NPBL75, NPBL70, NPBL76, NNBLG2, NPBMFG, NPBMF4, NPBMF2, NPBMF1, NPBMF5, NPBMH2, NPBMH0, NNBLJM, NNBLJK, NNBLJN, NNBLHZ, NNBLHW, NNBLH2, NNBLH1, NNBLH0, NNBLTB, NNBLL4, NPBL1R, NPBL1P, NPBL1N, NPBL1L, NPBL1J, NPBL9N, NPBL9K, NPBL9L, NNBLHN, NNBLGV, NNBLHT, NNBLHM, NNBLG0, NNBLLK, NMBKBW, NMBJ5G
• Recalling Firm/ Manufacturer: Codman & Shurtleff, Inc.; 325 Paramount Drive; Raynham MA 02767
• Manufacturer Reason for Recall: A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.
• FDA Determined Cause: Device Design
• Action: Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at Codmanproductcomplaints@dpyus.jnj.com We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to
• Quantity in Commerce: 90
• Distribution: Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LKK and Original Applicant = Intera Oncology