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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86788

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

Open FDA event record

Event summary

Timeline bucket
January 06, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

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

Infusion Pump

Z-1150-2021
Recall number
Z-1150-2021
Initiated
January 06, 2021
Classification
Class II
Status
Terminated
Quantity
589,704 total units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Battery performance issues related to prolonged storage.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Battery performance issues related to prolonged storage.

Code information

Infusion Pump Product codes: 35700ABB, 35700BAX, and 35700BAX2 Battery codes: 35083, 35162, 35195, and 35724. Infusion Pump Product codes: 35700ABB, 35700BAX, 35700BAX2 3570009 Battery codes: 35223 and 36010

Distribution pattern

Domestic Distribution: ST, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico. International Distribution: Canada, Barbados, Bermuda, St. Thomas, Guyana, Trinidad and Tobago, Jamaica and Nassau Bahamas.