Exact FDA event identifier

Event 81113

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

Open FDA event record

Event summary

Timeline bucket: September 04, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cypress Medical Products 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

McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.

Z-0119-2019

Recall number: Z-0119-2019
Initiated: September 04, 2018
Classification: Class II
Status: Terminated
Recalling firm: Cypress Medical Products LLC
Quantity: 400 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Small hole at the end of the syringe is impeding suction of liquid.

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

Small hole at the end of the syringe is impeding suction of liquid.

Code information

Lot Code: KSH0603

Distribution pattern

US Nationwide Distribution