Recall events
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Event 84365
Event summary
Timeline bucket November 20, 2019
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording B. Braun Medical, 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
7 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 7
Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005
Z-0935-2020
Recall number Z-0935-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 1,824 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0935-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3256]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046955202799 Lot Numbers: 61679395 - Expiration Date: May 31, 2022, 61685454 - Expiration Date: June 30, 2022
Distribution pattern US Nationwide
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[30421]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 7
Y-Type Blood Set, Catalog Number 490293
Z-0936-2020
Recall number Z-0936-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 1,050 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0936-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[15156]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046964539657 Lot Number: 61681734 Expiration Date: May 31, 2022
Distribution pattern US Nationwide
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[29578]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 7
Y-Type Blood Set, Catalog Number 490314
Z-0937-2020
Recall number Z-0937-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 5,616 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0937-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38692]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046964527180 Lot Numbers: 61674868 - Expiration Date April 30, 2022, 61677175 - Expiration Date April 30, 2022, 61678259 - Expiration Date May 31, 2022, 61685087 - Expiration Date June 30, 2022
Distribution pattern US Nationwide
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[29507]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 7
Y-Type Blood Set, Catalog Number 490425
Z-0938-2020
Recall number Z-0938-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 2,736 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0938-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9098]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046964813702 Lot Numbers: 61674871 - Expiration Date: April 30, 2022, 61680607 - Expiration Date: May 31, 2022, 61685094 - Expiration Date: June 30, 2022
Distribution pattern US Nationwide
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[29489]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 7
Y-Type Blood Set, Catalog Number 490530
Z-0939-2020
Recall number Z-0939-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 9,000 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0939-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3257]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046955203321 Lot Numbers: 61674878 - Expiration Date: April 30, 2022, 61677192 - Expiration Date: April 30, 2022, 61678186 - Expiration Date: April 30, 2022, 61681736 - Expiration Date: May 31, 2022, 61685105 - Expiration Date: June 30, 2022
Distribution pattern US Nationwide
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[29641]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 7
Safeline Y-Type Blood Set, Catalog Number NF5140
Z-0940-2020
Recall number Z-0940-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 3,300 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0940-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[38696]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046964187483 Lot Numbers: 61681745 - Expiration Date: May 31, 2024, 61685109 - Expiration Date: June 30, 2024
Distribution pattern US Nationwide
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[30531]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 7
Safeline Y-Type Blood Set, Catalog Number V2500
Z-0941-2020
Recall number Z-0941-2020
Initiated November 20, 2019
Classification Class II
Status Terminated
Quantity 19,500 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential for leakage at the joint between the blood filters and tubing
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-0941-2020
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21608]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential for leakage at the joint between the blood filters and tubing
Code information GUIDID: 04046964188633 Lot Numbers: 61674884 - Expiration Date: April 30, 2024, 61677634 - Expiration Date: April 30, 2024, 61678262 - Expiration Date: May 31, 2024, 61680625 - Expiration Date: May 31, 2024, 61685110 - Expiration Date: June 30, 2024
Distribution pattern US Nationwide
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[30518]
FDA event record
· Exact recall-number query on openFDA
