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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88963

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries 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

5 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 5

EVLP Convenience Pack/Kit

Z-0358-2022
Recall number
Z-0358-2022
Initiated
October 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information

Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998

Distribution pattern

US Nationwide distribution.

device · product 2 of 5

Neuro Convenience Kit

Z-0359-2022
Recall number
Z-0359-2022
Initiated
October 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information

Model #: DYNJ905194 Lot #: 19HBK497 UDI: GTIN (01)40889942837466 EXP (17)2021-04-30 LOT (10)19HBK497

Distribution pattern

US Nationwide distribution.

device · product 3 of 5

Major Vascular CDS Convenience Kit

Z-0360-2022
Recall number
Z-0360-2022
Initiated
October 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information

Model #: CDS981543D Lot #: 19HBK745 UDI: GTIN (01)4088277523976 EXP (17)2021-07-31 LOT (10)19HBK745

Distribution pattern

US Nationwide distribution.

device · product 4 of 5

Venous Access Pack-LF Convenience Kit

Z-0361-2022
Recall number
Z-0361-2022
Initiated
October 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information

Model #: DYNJ36725B Lot #: 19UBB149 UDI: GTIN (01)40889942389163 EXP (17)2021-07-31 LOT (10)19UBB149

Distribution pattern

US Nationwide distribution.

device · product 5 of 5

Bedside PICC CDS Convenience Kit

Z-0362-2022
Recall number
Z-0362-2022
Initiated
October 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

Code information

Model #: CDS984642 Lot #: 19JBB553 UDI: GTIN (01)40884389882825 EXP (17)2021-09-30 LOT (10)19JBB553

Distribution pattern

US Nationwide distribution.