Z-1271-2018 Class II Terminated
FDA device recall Z-1271-2018 was initiated by Medical Components, Inc dba MedComp on November 22, 2017 and is designated Class II. Reason for recall: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire. The recall status is terminated (terminated July 11, 2018). Affected quantity: 24 Eaches.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- November 22, 2017
- Termination Date
- July 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 Eaches
Product Description
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Reason for Recall
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Distribution Pattern
CA, AR. AL
Code Information
Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449