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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68030

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 16, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Corporation Englewood

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

1 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 1

RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syringe Strip, Gray. H93890232 RAPIDFILL Syringe Strip, Green. Sterile 10 ml syringes with twist-off luer sealing tip caps banded together with label material.

Z-1620-2014
Recall number
Z-1620-2014
Initiated
April 16, 2014
Classification
Class II
Status
Terminated
Quantity
774, 600

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in sterile barrier

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

Possible breach in sterile barrier for inner and outer bags of the product.

Code information

Product Code: H93890200 Lots 787032 to 790790; Codes H93890221 Lots 789096 to 791247; Code H93890222 Lots 787761 to 790791; Code H93890223 Lots 786926 to 789793; Code H93890225 Lots 789794 to 790792; Code H93890227 Lots 789098 to 791246; Code H93890229 Lots 789637 to 790794; Code H93890231 Lots 788465 to 790795; Code H93890232 Lots 790796 to 791245

Distribution pattern

Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada.