The Recall Desk
HighFDA (Devices)·Z-0832-2018·Announced 2018-03-07

Cook Recalls Wills-Oglesby Percutaneous Gastrostomy Sets Due to Wire Guide Defect

Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets because wire guides may be loaded backwards into the holder.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a medical device used for invasive procedures. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.

Plain-English summary

Cook Inc. is recalling Wills-Oglesby Percutaneous Gastrostomy Sets, which are intended for the percutaneous placement of a catheter for gastroenteric feeding. The recall is due to a defect where wire guides may have been loaded backwards into the wire guide holder.

The affected product is identified by the code WOGS-1200 and includes specific lot numbers: 6709866, 7092684, 7225148, 7315120, 7360624, 7428977, 7464543, 7523606, 7580747, 7580749, 7852593, 7897499, 7981709, and 8032023. The source text notes that quantities are co-mingled into line 1.

The recall involves US Nationwide Distribution. The source text does not specify the total number of units affected or report any specific injuries or illnesses associated with this defect.

The recalled product

Product
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Manufacturer
Cook Inc.
Affected units
1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →