Recall events
/
Event 84889
Event summary
Timeline bucket February 04, 2020
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Deroyal Industries, Inc. Lafollette
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
10 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 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
Z-1410-2020
Recall number Z-1410-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2,100 units total
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1410-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57077]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Outpatient Major 89-3865.12, Lot numbers: 47061206 exp. 06/01/2022, 49505579 exp. 03/01/2023, 4955103 exp. 03/01/2023
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30513]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Chronic Ear Pack 89-4393.17
Z-1411-2020
Recall number Z-1411-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1411-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11288]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Chronic Ear Pack 89-4393.17, Lot number: 49241024 exp. 07/01/2020;
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30739]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
Z-1412-2020
Recall number Z-1412-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1412-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21611]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Shoulder Pack 89-4751.08, Lot number: 49505405 exp. 11/01/2021
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30714]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16
Z-1413-2020
Recall number Z-1413-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1413-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21620]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC General Pack 89-6015.16, Lot Numbers: 49215900 exp. 06/01/2023, 49266256 exp. 06/01/2023;
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30735]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
Z-1414-2020
Recall number Z-1414-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1414-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[44684]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Cystoscopy Pack 89-6071.15, Lot number: 49442168 exp 03/01/2021;
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30519]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Z-1415-2020
Recall number Z-1415-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1415-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50433]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; f. ASC Laparoscopy Pack 89-6138.13, Lot number: 49505093 exp.10/01/2023;
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30535]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14
Z-1416-2020
Recall number Z-1416-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1416-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57085]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Thyroid Pack 89-6302.14, Lot numbers: 49310958 exp. 09/01/2023, 49675501 exp. 09/01/203
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30691]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Ophthalmology CSTM PCK 89-6387.08
Z-1417-2020
Recall number Z-1417-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1417-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15188]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Opthalmology CSTM PCK 89-6387.08, Lot number: 49512592 exp. 07/01/2022
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30776]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 10
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Kwik Kit 89-6389.06
Z-1418-2020
Recall number Z-1418-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1418-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3271]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; Kwik Kit 89-6389.06, Lot number: 49624025 exp. 07/01/2023
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[30620]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-1419-2020
Initiated February 04, 2020
Classification Class II
Status Terminated
Quantity 2100 units
App-derived interpretation
Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0
particulate
Microbial contamination
reason.microbial_contamination · v1.0.0
bioburden, unknown microbiological flora, and unknown particulate contamination
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Environmental control
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1419-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[11286]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Code information Catalog number 9541NA, lot numbers 2708DJ1, 3008DJ1, 3008DSJ1 and 4418GSJ; ASC Ocular Plastics Pack 89-6498.13, Lot numbers: 49227281 exp. 08/01/2023, 49520963 exp. 09/01/2023
Distribution pattern US: Rhode Island and New Jersey Federal government agency: V.A Med Ctr East Orange
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[31017]
FDA event record
· Exact recall-number query on openFDA
