Recall events
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Event 89875
Event summary
Timeline bucket March 18, 2022
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording ROi CPS LLC
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
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
Z-1004-2022
Recall number Z-1004-2022
Initiated March 18, 2022
Classification Class II
Status Terminated
Quantity 290 convenience kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1004-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58592]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Reason for recall A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Code information (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.
Distribution pattern US Nationwide distribution in the state of Missouri.
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[36946]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
Z-1005-2022
Recall number Z-1005-2022
Initiated March 18, 2022
Classification Class II
Status Terminated
Quantity 1,501 convenience kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1005-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[58593]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
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Inspect official wording and provenance
Reason for recall A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Code information (1) Item Number: 830015013 - Lot numbers 87230M, exp. 5/31/2022; 87954M, exp. 5/31/2022; 88285M, exp. 5/31/2022; 88999M, exp. 6/30/2022; 89494, exp. 5/31/2022; 89985, exp. 6/30/2022; 90866, exp. 6/30/2022; and 91603, exp. 5/31/2023; and (2) Item 830084003 - Lot numbers 86155C, exp. 3/31/2022; 84799C, exp. 3/31/2022; 86735C. exp. 3/31/2022, 87269C, exp. 7/31/2022; 87871C, exp. 7/31/2022; 88564C, exp. 1/31/2023; 89260, exp. 2/28/2023; 89820, exp. 2/28/2023; 90253, exp. 1/31/2023; 90594, exp. 12/31/2022; and 91335, exp. 12/31/2022.
Distribution pattern US Nationwide distribution in the state of Missouri.
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[37440]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Z-1006-2022
Recall number Z-1006-2022
Initiated March 18, 2022
Classification Class II
Status Terminated
Quantity 950 convenience kits
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1006-2022
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33592]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
Code information Lot numbers 89889, exp. 5/12/2022; 90446, exp. 5/12/2022; and 90641, exp. 5/12/2022.
Distribution pattern US Nationwide distribution in the state of Missouri.
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[36942]
FDA event record
· Exact recall-number query on openFDA
