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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90834

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

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Event summary

Timeline bucket
September 08, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SunMed Holdings, LLC

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

Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

Z-1779-2022
Recall number
Z-1779-2022
Initiated
September 08, 2022
Classification
Class II
Status
Terminated
Recalling firm
SunMed Holdings, LLC
Quantity
53,560 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
lack of sterility

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

The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

Code information

UDI-DI: 00709078004483 (each label); 10709078004480 (box label) Lots 010822N23, 052521N54, 081821N05, 101221N11

Distribution pattern

Domestic distribution to AL, FL, GA, IL, LA, MO, NJ, NY, TN, TX.