Z-2239-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 30, 2021
- Termination Date
- February 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 760 UNITS
Product Description
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Reason for Recall
There is a potential that 7F sheaths are packaged as 10F sheaths.
Distribution Pattern
US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
Code Information
Lot # I2059849