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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84681

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD, 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

2 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 2

Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

Z-1715-2020
Recall number
Z-1715-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
720,100 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Code information

Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

Distribution pattern

USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

device · product 2 of 2

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Z-1716-2020
Recall number
Z-1716-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD, Inc.
Quantity
127,700 total devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

Code information

Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727

Distribution pattern

USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

Field note

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