PlainRecalls
FDA Devices Moderate Class II Terminated

Left Atrial Catheter Set

Reported: March 21, 2018 Initiated: October 13, 2017 #Z-0965-2018

Product Description

Left Atrial Catheter Set

Reason for Recall

Label does not state that the product is heparin-coated.

Details

Recalling Firm
Cook Inc.
Units Affected
56
Distribution
Nationally
Location
Bloomington, IN

Frequently Asked Questions

What product was recalled?
Left Atrial Catheter Set. Recalled by Cook Inc.. Units affected: 56.
Why was this product recalled?
Label does not state that the product is heparin-coated.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0965-2018.