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U.S. Department of Health and Human Services

Class 2 Device Recall BARD MAXCORE Disposable Core Biopsy Instrument

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 Class 2 Device Recall BARD MAXCORE Disposable Core Biopsy Instrumentsee related information
Date Initiated by FirmSeptember 22, 2017
Create DateOctober 20, 2017
Recall Status1 Terminated 3 on September 27, 2018
Recall NumberZ-0044-2018
Recall Event ID 78224
510(K)NumberK133948 
Product Classification Instrument, biopsy - Product Code KNW
ProductBARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Code Information Lot Numbers: REBP0019, REBN0342, REBN2123, REBP1199, REBP1419, REBP1807, REBQ0084, REBQ0343, REBQ1012, REBP1420, REBP1809, REBP0869, REBP1266, REBP1267, REBP1421, REBP1422, REBP1810, REBQ0087, REBQ0088, REBQ0347, REBQ0811, REBQ1014, REBP0158, REBQ1904, REBQ1898, REBQ1978, REBR0468, REBQ2296, REBR0474
Recalling Firm/
Manufacturer		 Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
Tempe AZ 85281-2438
For Additional Information ContactRaye Seisinger
800-994-6772 Ext. 2501
Manufacturer Reason
for Recall		During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation.
FDA Determined
Cause 2		Device Design
ActionBPV sent a customer recall letter on September 22, 2017 to each of the US consignees via FedEx with proof of delivery notification. BPV will also initiate a recall for product outside the US in accordance with regulations of each country in which the product was distributed.
Quantity in Commerce110,550 units
DistributionUS, Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific
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 = KNW
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