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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85206

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

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Event summary

Timeline bucket
January 14, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CME America, LLC

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

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.

Z-1886-2020
Recall number
Z-1886-2020
Initiated
January 14, 2020
Classification
Class II
Status
Terminated
Recalling firm
CME America, LLC
Quantity
5,800 infusion sets from lot 90829 and 24,500 from lot 16201

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The filter installed onto the tube set may have the incorrect pore size.

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

The filter installed onto the tube set may have the incorrect pore size.

Code information

Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201

Distribution pattern

US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.