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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89952

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

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Event summary

Timeline bucket
March 08, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
SIMPLIVIA HEALTHCARE LTD.

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

OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143

Z-1057-2022
Recall number
Z-1057-2022
Initiated
March 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
SIMPLIVIA HEALTHCARE LTD.
Quantity
293,520

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

Code information

UDI: 37290115921435, Lots: UBE507, UBE508, UBE513, UBE516, UBE517, UBE509, UBE511, UBE512, UBE514, UBE515, UBE517, UBE518, UBE526, UBE530, UBE531, UBE534, UBE533, UBE535, UBE536

Distribution pattern

Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.