Z-0979-2019 Class I Terminated
FDA device recall Z-0979-2019 was initiated by Cook Inc. on February 1, 2019 and is designated Class I. Reason for recall: The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion. The recall status is terminated (terminated June 30, 2020). Affected quantity: 100.
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- February 1, 2019
- Termination Date
- June 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100
Product Description
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Reason for Recall
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
Distribution Pattern
US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.
Code Information
Lot 8833687