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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70313

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Arrow International 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

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

Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

Z-1030-2015
Recall number
Z-1030-2015
Initiated
January 09, 2015
Classification
Class III
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
4484

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

Code information

Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120

Distribution pattern

US (nationwide) and PR.