FDAClass IIJune 12, 2019

Pericardiocentesis Catheter Set recall

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

Why was Pericardiocentesis Catheter Set recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers 7716007 7703324 NS7703501 NS7703502 NS7703503 NS7704718 NS7704722 NS7704727 NS7704728

Product
Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
Recalling firm
Cook Inc.
Quantity
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
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls