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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70007

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

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Event summary

Timeline bucket
November 13, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Aptalis Pharmatech 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

FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.

Z-1006-2015
Recall number
Z-1006-2015
Initiated
November 13, 2014
Classification
Class II
Status
Terminated
Recalling firm
Aptalis Pharmatech Inc.
Quantity
Approximately 49,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customer notification that the device may be difficult to open or close.

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

Customer notification that the device may be difficult to open or close.

Code information

The affected products has lot numbers S46 and S47.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of OH, NM, CO, NC, IL, MD, LA, MN, NJ, SC, AL, VA, MI, MA, and CA. in the countries of: Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.