Recall events
/
Event 81179
Event summary
Timeline bucket August 13, 2018
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Custom Healthcare Systems, Inc.
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
29 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 29
CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B
Z-0240-2019
Recall number Z-0240-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 200 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0240-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10877]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot Number: 70618 Exp. Date: 9/1/2020
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[21288]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 29
CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
Z-0241-2019
Recall number Z-0241-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 40 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0241-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20829]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot Number: 70518, Exp. Date: 2/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26964]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 29
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
Z-0242-2019
Recall number Z-0242-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity (1) 750 units (2) 200 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0242-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26976]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information (1)Lot Number:72018 Exp. Date: 7/1/2021 (2) Lot number: 71118 Exp. Date: 7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27839]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 29
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Z-0243-2019
Recall number Z-0243-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0243-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3962]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27779]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 29
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Z-0244-2019
Recall number Z-0244-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0244-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10875]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27226]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 29
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Z-0245-2019
Recall number Z-0245-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 30 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0245-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39369]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27369]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 29
CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
Z-0246-2019
Recall number Z-0246-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 160 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0246-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39371]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27404]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 29
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Z-0247-2019
Recall number Z-0247-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 100 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0247-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50347]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27929]
FDA event record
· Exact recall-number query on openFDA
device · product 9 of 29
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Z-0248-2019
Recall number Z-0248-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0248-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39377]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26946]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0249-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity (1) 180 units (2)180 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0249-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[39376]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information (1)Lot number: 52418, 51418 Exp. Date: 5/1/2021 (2) Lot Number:51418 Exp Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27421]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0250-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 630 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0250-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26975]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 70618 Exp. Date:1/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26936]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0251-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 250 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0251-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50342]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51018 Exp. Date:5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27379]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0252-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 72 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0252-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15533]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 61918 Exp. Date: 6/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27239]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0253-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 80 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0253-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26980]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: (1) 71718 Exp. Date: 7/1/2021 (2) 70618 Exp Date: 7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27844]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0254-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0254-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10878]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number:51018 Exp. Date 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27626]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0255-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0255-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15534]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27673]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0256-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 50 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0256-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50341]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27833]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0257-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0257-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34312]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp. Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27968]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0258-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 150 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0258-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34314]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp. Date: 2/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27992]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0259-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 1250 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0259-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[34310]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number:51018 Exp Date: 5/1/2021 Exp. Date: 2/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27295]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0260-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 24 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0260-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57228]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 51418 Exp Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27798]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0261-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 48 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0261-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[57226]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 61518 Exp Date: 12/1/2020
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27777]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0262-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 100 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0262-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3972]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number: 52418 Exp Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26976]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0263-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 60 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0263-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[50346]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot number:52418 Exp Date: 5/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27004]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0264-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 7200 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0264-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45695]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot numbers: W72018, W71218 Exp Date:7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27861]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0265-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 89 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0265-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26970]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot Number: :W72118 Exp Date:7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26996]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0266-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 72832 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0266-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[45694]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information (1)1231-150L GOWN, RAGLAN, LG, NONREINF Lot Numbers: W72318,W72118 (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF Lot Number: W72318 (3) 1231-140XL GOWN, SPECIALTY XL, XLONG Lot Number: W71818 Exp. Date: 7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[26931]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0267-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 4500 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0267-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[20831]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot Number: W72118 Exp. date: 7/1/2021
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27284]
FDA event record
· Exact recall-number query on openFDA
Recall number Z-0268-2019
Initiated August 13, 2018
Classification Class II
Status Terminated
Quantity 300 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Packaging
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0268-2019
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15535]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Code information Lot Number: 61518 Exp. date: 8/1/2020
Distribution pattern Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
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[27270]
FDA event record
· Exact recall-number query on openFDA
