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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64841

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 21, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Hospira 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

2 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 2

The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.

Z-1116-2013
Recall number
Z-1116-2013
Initiated
March 21, 2013
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

Code information

List Numbers: 13000, 13100, 13150

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.

device · product 2 of 2

The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.

Z-1117-2013
Recall number
Z-1117-2013
Initiated
March 21, 2013
Classification
Class II
Status
Terminated
Recalling firm
Hospira Inc.
Quantity
1) List Number 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.

Code information

List Numbers: 13086, 13087, 13088

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.