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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98720

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

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Event summary

Timeline bucket
March 19, 2026
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
American Contract Systems 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

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

Z-1981-2026
Recall number
Z-1981-2026
Initiated
March 19, 2026
Classification
Class I
Status
Ongoing
Quantity
7,311 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

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

Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.

Code information

ANCA80AP UDI-DI 191072232168 Lot 42-8146111 ANCA80AQ UDI-DI 191072236678 Lots 42-8207211 42-8267711 42-8311311 42-8337611 42-8353311 42-8379211 42-8407111 42-8510711 42-8575111 42-8611511 42-8718911 42-8718912 42-8722611 42-8805311 42-8820611 42-8870911

Distribution pattern

US distribution to MN. No OUS distribution.