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Class 2 Device Recall BK Medical |
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Date Initiated by Firm |
January 24, 2008 |
Date Posted |
June 10, 2008 |
Recall Status1 |
Terminated 3 on June 23, 2008 |
Recall Number |
Z-1140-2008 |
Recall Event ID |
46394 |
510(K)Number |
K024236 K043524
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Product Classification |
ultrasound transducer - Product Code IYN
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Product |
B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887 |
Code Information |
Serial Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and 1875317. |
Recalling Firm/ Manufacturer |
B & K Medical Systems, Inc. 250 Andover St Wilmington MA 01887-1048
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For Additional Information Contact |
SAME 800-876-7226
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Manufacturer Reason for Recall |
Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.
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FDA Determined Cause 2 |
Process control |
Action |
B-K Medical issued letter notification on 1/23/08 to accounts via Fed Ex, advising them not to use the unit until a representative can inspect and exchange, if unit is found defective. Instructions are also provided to continue use of the device with a sterile cover until site visit. |
Quantity in Commerce |
7 |
Distribution |
USA Distribution: MA, MI, PA, TX, and OR. |
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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510(K) Database |
510(K)s with Product Code = IYN and Original Applicant = B-K MEDICAL A/S
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