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U.S. Department of Health and Human Services

Class 2 Device Recall Coaxial MicroIntroducer Kit

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  Class 2 Device Recall Coaxial MicroIntroducer Kit see related information
Date Initiated by Firm April 28, 2014
Date Posted May 13, 2014
Recall Status1 Open3, Classified
Recall Number Z-1614-2014
Recall Event ID 68161
510(K)Number K990705  
Product Classification Introducer, catheter - Product Code DYB
Product Coaxial Micro-Introducer Kit.
Greatbatch Part Number/Bard Access Systems Order Number/Part Description

10636-001
8004011
Kit Coax 10 Pack 4FR Bard

10636-002
8005011
Kit Coax 10 Pack 5FR Bard

10636-007
8004012
Kit Coax 10 Pack 4FR Bard

10636-008
8005012
Kit Coax 10 Pack 5FR Bard

10636-009
8004022
Kit Coax 10 Pack 5FR Bard

10636-010
8005022
Kit Coax 10 Pack 5FR Bard

The Coaxial Micro-Introducer set contains a 21 gauge disposable introducer needle, 0.018 inch floppy tip guidewire, and a radiopaque Coaxial Micro Introducer consisting of a sheath and dilator. The Coaxial Micro-Introducer Set is used to introduce up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick.
Code Information W1190519, W1190532, W1190532, W1190514, W1190517, W1190517, W1190516, W1266849, W1266851, W1266850, W1266848, W1298418, W1300005, W1298419, W1298425, W1298426, W1362771, W1362772, W1362773, W1362775, W1383678, W1362774, W1420240, W1420241, W1420242, W1434887, W1434888, W1464513, W1464514, W1464516, W1464511, W1464512, W1464515, W1466090, W1466092, W1466093, W1466091, W1467421, W1477933, W1467420, W1477935, W1477932, W1477934, W1490379, W1477937, W1490378, W1490380, W1490377, W1477936, W1509174, W1509175, W1532502, W1532501, W1509173, W1599234, W1629461, W1661254, W1688745, W1720426, W1746962, W1720428, W1792523, W1786461, W1788967, W1770099, W1807382, W1807383, W1807378, W1872468, W1872469, W1872470, W1927797, W1872468, W1927798, W1927799, W1963380, W2012849, W2012851, W2012850, W2047027, W2058073, W2047028, W2073401, W2047030, W2047031, W2094903, W2110798, W2170053, W2155950, W2170050, W2170052, W2192990, W2211695, W2211696, W2211697, W2268277, W2268271, W2315849, W2315850, W2315845, W2315846, W2315848, W2357893, W2357894, W2371770, W2371771, W2392043, W2357895, W2357896, W2397846, W2371772, W2386295, W2451688, W2451690, W2451691, W2451692, W2451693, W2461057, W2461056, W2461058, W2513845, W2561761, W2561762
Recalling Firm/
Manufacturer
Greatbatch Medical
2300 Berkshire Ln N
Minneapolis MN 55441-4575
For Additional Information Contact local Greatbatch representative
763-951-8235
Manufacturer Reason
for Recall
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.
FDA Determined
Cause 2
Incorrect or no expiration date
Action Greatbatch sent an "Urgent Medical Device Recall" letter dated April 25, 2014 to affected customers via email and Fedex. The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to immediately place affected devices in quarantine and to complete and return the Field Correction Action Response Form. For questions they should contact their local Greatbatch representative or 1-763-951-8235, or e-mail FieldActionCenter@Greatbatch.com.
Quantity in Commerce 6,642 sets (66,420 devices)
Distribution US Nationwide Distribution in the state of UT.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = MEDAMICUS, INC.
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