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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79192

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook 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

3 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 3

Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Z-0830-2018
Recall number
Z-0830-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
615

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

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

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Code information

WOGS-1400 -MKOT-A Lot numbers: 6869315 6908857 7034661 7106057 7193431 7252317 7635697 7744001 7811587 8025220 8076495

Distribution pattern

US Nationwide Distribution

device · product 2 of 3

Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Z-0831-2018
Recall number
Z-0831-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
Quantities co-mingled into line 1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

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

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Code information

WOGS-1200-WH- 050493 Lot number: NS7587941

Distribution pattern

US Nationwide Distribution

device · product 3 of 3

Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding

Z-0832-2018
Recall number
Z-0832-2018
Initiated
October 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Cook Inc.
Quantity
Quantities co-mingled into line 1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

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

Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.

Code information

WOGS-1200 Lot numbers: 6709866 7092684 7225148 7315120 7360624 7428977 7464543 7523606 7580747 7580749 7852593 7897499 7981709 8032023

Distribution pattern

US Nationwide Distribution