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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68161

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 28, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Greatbatch Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1614-2014
Recall number
Z-1614-2014
Initiated
April 28, 2014
Classification
Class II
Status
Terminated
Recalling firm
Greatbatch Medical
Quantity
6,642 sets (66,420 devices)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

US Nationwide Distribution in the state of UT.

Field note

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