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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.

Open FDA event record

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.

Field note

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