| Class 3 Device Recall Hancock II Bioprostheses with Cinch | |
Date Initiated by Firm | January 26, 2009 |
Date Posted | May 29, 2009 |
Recall Status1 |
Terminated 3 on May 22, 2012 |
Recall Number | Z-1226-2009 |
Recall Event ID |
51220 |
PMA Number | P980043 |
Product Classification |
Replacement Heart-Valve - Product Code DYE
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Product | Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID;
Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca.
Indicated for the replacement of malfunctioning native or aortic and mitral heart valves. |
Code Information |
Lot Serial # 25A07L4976, 21A08D0985, 25A06H1684, 23A07T1262, 23A08B5266, 25A08F0564, 21A07R2878, 29M07V3883, 25M07T4827, and 27M07V0682. |
Recalling Firm/ Manufacturer |
Medtronic Inc 710 Medtronic Pkwy Minneapolis MN 55432-5603
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For Additional Information Contact | 763-505-2562 |
Manufacturer Reason for Recall | Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements. |
FDA Determined Cause 2 | Storage |
Action | A Medtronic "Urgent Medical Device Recall Notice" dated January 26, 2009, was sent to Risk Managers of each affected account and to each Implanting Physician. The letter described the problem, product and informed consignees that they will be retrieving the non-implanted vales. If additional information is needed, customers are to contact their local Medtronic sales representative or technical services at 1-877-526-7890. |
Quantity in Commerce | 10 |
Distribution | Nationwide Distribution -- Including states of CT, FL, MD, MA, MI, NC, OH, OR, PA, SD, TN, TX, WI, and WA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = DYE
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