PlainRecalls
FDA Devices Moderate Class II Terminated

Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

Reported: June 12, 2019 Initiated: April 9, 2019 #Z-1722-2019

Product Description

Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282

Reason for Recall

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

Details

Recalling Firm
Cook Inc.
Units Affected
83 kits
Distribution
Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282. Recalled by Cook Inc.. Units affected: 83 kits.
Why was this product recalled?
Affected products may have been manufactured with the catheter distal end hole too small
Which agency issued this recall?
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1722-2019.