Z-1073-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- December 4, 2017
- Termination Date
- June 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,077 units total
Product Description
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Reason for Recall
Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also contain the incorrect locking collars in addition to the incorrect sized introducer.
Distribution Pattern
Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Code Information
a. Item No. 21-4071-24 (Lot No. 86X046, 87X050); b. Item No. 21-8066-24 (Lot No. 87X178); c. Item No. 21-8068-24 (Lot No. 87X179)