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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84943

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Deroyal Industries, Inc. Lafollette

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

Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This device is used for cardiovascular surgical procedures.

Z-1483-2020
Recall number
Z-1483-2020
Initiated
February 06, 2020
Classification
Class II
Status
Terminated
Quantity
669 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile packaging has the potential to be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile packaging has the potential to be compromised.

Code information

Catalog Number DP40K; Lot Numbers: 74F1802710, 74G1802678, 74H1800763, 74D1900657, 74C1900811, 74D1700564

Distribution pattern

International distribution of Kuwait City, Kuwait.