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U.S. Department of Health and Human Services

Class 2 Device Recall BK Medical

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 Class 2 Device Recall BK Medicalsee related information
Date Initiated by FirmNovember 12, 2004
Date PostedDecember 02, 2004
Recall Status1 Terminated 3 on January 18, 2005
Recall NumberZ-0271-05
Recall Event ID 30410
510(K)NumberK024236 K991937 K000567 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
ProductLinear Array Transducer Type: 8809
Code Information Serial Numbers: 1831984 1831985 1831986 1831987 1831989 1831990 1831992 1832004 1832007 1844219 1844235 1844239 1844240 1844241 1847871 1847875 1847889 
FEI Number 1523841
Recalling Firm/
Manufacturer		 B & K Medical Systems Inc.
267 Boston Rd
North Billerica MA 01862-2310
For Additional Information ContactLars Larsen
800-645-4442
Manufacturer Reason
for Recall		Defect at probe tip may effect sterilization and electrical safety
FDA Determined
Cause 2		Other
ActionBK Medical Wilmington, MA notified accounts by letter dated 11/ 12 /04 via UPS Overnight.. Accounts are requested to return the unit.
Quantity in Commerce17 units
DistributionCA, CO, CT, FL, LA, GA, NJ, NY, VA, VT
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = IYN
510(K)s with Product Code = IYN
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