Exact FDA event identifier

Event 88807

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

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Event summary

Timeline bucket: September 14, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bayer Medical Care, 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

The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

Z-0199-2022

Recall number: Z-0199-2022
Initiated: September 14, 2021
Classification: Class II
Status: Terminated
Recalling firm: Bayer Medical Care, Inc.
Quantity: 6,950 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)

Code information

Batch number: 8415317

Distribution pattern

Worldwide distribution - US Nationwide and the countries of AU, BY, DE, DK, GB, HR, NL, NZ, RU, SE, TH.