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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62909

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

Open FDA event record

Event summary

Timeline bucket
August 02, 2012
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

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

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

Z-2346-2012
Recall number
Z-2346-2012
Initiated
August 02, 2012
Classification
Class II
Status
Terminated
Recalling firm
Hospira, Inc.
Quantity
unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports of leaking during filling and administration.

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

Reports of leaking during filling and administration.

Code information

The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.

Distribution pattern

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.