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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 Posted May 13, 2014
Recall Status1 Terminated
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = MEDAMICUS, INC.
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