Recall events
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Event 83324
Event summary
Timeline bucket March 13, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Medical Components, Inc dba MedComp
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
3 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 3
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Z-2215-2019
Recall number Z-2215-2019
Initiated March 13, 2019
Classification Class II
Status Terminated
Quantity 6830
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2215-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[4007]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Code information MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410 MCFB340 MCFG840 MCFL120 MCFP220 MCFT420 MCFZ280 MKAF340 MKAG480 MKAN280 MKAT110 MKAX330 MKBA730 MKBH920 MKBN710 MKBX790 MMAB370 MMAD450 MMAQ940
Distribution pattern US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29150]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Z-2216-2019
Recall number Z-2216-2019
Initiated March 13, 2019
Classification Class II
Status Terminated
Quantity 6830
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2216-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44577]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Code information MCAL430 MCAT000 MCBM770 MCBS380 MCCC840 MCCM930 MCCS360 MCCZ450 MCDC580 MCDN120 MCDR420 MCFB350 MCFG980 MCFM410 MCFP230 MCFT430 MCFZ290 MKAF350 MKAG490 MKAM210 MKAR120 MKBA200 MKBL090 MKBL220 MKBV580 MMAB710 MMAM070 MMAQ950
Distribution pattern US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[29201]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Z-2217-2019
Recall number Z-2217-2019
Initiated March 13, 2019
Classification Class II
Status Terminated
Quantity 6830
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Labeling Change Control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-2217-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38644]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Code information MCAM240 MCBL480 MCBS870 MCCF480 MCCJ320 MCCW690 MCCZ500 MCFG830 MCFR160 MCFS760 MCFZ360 MKAJ330 MKAR130 MKBL500 MKBX060 MMAB730
Distribution pattern US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[28799]
FDA event record
· Exact recall-number query on openFDA
