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Recall Observatory FDA recall evidence

Device product

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

Z-0831-2018

October 19, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 79192
Status
Terminated
Classification
Class II
Quantity
Quantities co-mingled into line 1
Official record key
device-enforcement:Z-0831-2018

Official wording

Reason: 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

Derived failure modes

  • 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.