Z-1780-2019 Class II Terminated
FDA device recall Z-1780-2019 was initiated by Cook Inc. on May 2, 2019 and is designated Class II. Reason for recall: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. The recall status is terminated (terminated August 23, 2019). Affected quantity: 97.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- August 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97
Product Description
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Reason for Recall
The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
Distribution Pattern
No distribution in the US. Products were distributed to the following foreign countries: China.
Code Information
lot 8373482