The Recall Desk
SevereFDA (Devices)·Z-1723-2019·Announced 2019-06-12

Cook Inc. Recalls Pericardiocentesis Catheter Trays Due to Small Distal Hole

Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric.

Plain-English summary

Cook Inc. is recalling two units of the Pericardiocentesis Catheter Tray, model RPN C-PCYS-850, Order # G03284. The recall is due to a manufacturing defect where the catheter distal end hole may be too small.

The affected product is identified by Lot Number NS7726043. The units were distributed domestically in Ohio and internationally to Canada, Spain, Italy, Belgium, Germany, the United Arab Emirates, Greece, Switzerland, Oman, Monaco, Saudi Arabia, Australia, Hong Kong, India, and Korea.

This is a Class II recall. Users should stop using the affected devices and contact Cook Inc. for further instructions.

The recalled product

Product
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Manufacturer
Cook Inc.
Category
Medical Device — Catheter
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number NS7726043

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · manufacturing defect

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