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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73053

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

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Event summary

Timeline bucket
December 29, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pharmacaribe 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

PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx Product Usage: The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.

Z-0795-2016
Recall number
Z-0795-2016
Initiated
December 29, 2015
Classification
Class II
Status
Terminated
Recalling firm
Pharmacaribe llc
Quantity
7,020 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)

Code information

Lot # CIY Exp.Date August 2017 UPC Number: 030915339988 (on the box of 60 vials) UPC Number: 10030915339985 (on the shipping case of 12 boxes)

Distribution pattern

US Nationwide Distribution in the states of FL, LA, TX and VA