The Recall Desk
HighFDA (Devices)·Z-1725-2019·Announced 2019-06-12

Cook Inc. Recalls Thoracentesis Sets with Small Catheter Holes

Cook Inc. is recalling 5 units of Thoracentesis Sets (Lot NS7662071) because the catheter distal end hole may be too small.

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 involves a medical device defect (catheter hole too small) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 5 units of Thoracentesis Sets, model RPN C-THS-850, Order # G03286, Lot Number NS7662071. The recall was initiated because the affected products may have been manufactured with the catheter distal end hole too small.

The affected 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.

Healthcare providers and consumers should stop using the affected products and contact Cook Inc. for further instructions.

The recalled product

Product
Thoracentesis Set, RPN C-THS-850, Order # G03286
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
5

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 NS7662071

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

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Same hazard · defective design

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