CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

Thoracentesis Set, RPN C-ths-850, Order # G03286 recalled by Cook

Cook is recalling Thoracentesis Set, RPN C-ths-850, Order # G03286, distributed nationwide in the US. The recall was initiated on 9 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number NS7662071
Quantity recalled5 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1725-2019
FDA event ID
82692
Recalling firm
Cook, Bloomington, IN
Classification
Class II
Status
Terminated
Recall initiated
9 Apr 2019
FDA classified
4 Jun 2019
Reported
12 Jun 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

9 Apr 2019Recall initiated by company
4 Jun 2019Classified by FDA+56 days
12 Jun 2019Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Affected products may have been manufactured with the catheter distal end hole too small

Product as listed by the FDA

Thoracentesis Set, RPN C-THS-850, Order # G03286

Where it was distributed

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

Nationwide Ohio

Questions about this recall

Is Thoracentesis Set, RPN C-ths-850, Order # G03286 recalled?

Yes. Cook recalled Thoracentesis Set, RPN C-ths-850, Order # G03286 on 9 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1725-2019.

Why was it recalled?

Affected products may have been manufactured with the catheter distal end hole too small

Which lots are affected?

Lot Number NS7662071

Where was it sold?

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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