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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82197

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

Open FDA event record

Event summary

Timeline bucket
February 04, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
CP Medical 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

Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.

Z-1027-2019
Recall number
Z-1027-2019
Initiated
February 04, 2019
Classification
Class II
Status
Ongoing
Recalling firm
CP Medical Inc
Quantity
1,905 boxes (22,860 sutures total)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.

Code information

Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)

Distribution pattern

Worldwide Distribution - US Nationwide to IA, IL, NY, SC. Distributed internationally to Canada.