Device product
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Z-2238-2021
Product summary
- Event
- Event 88315
- Status
- Terminated
- Classification
- Class II
- Quantity
- 760 units
- Official record key
device-enforcement:Z-2238-2021
Official wording
Reason: There is a potential that 7F sheaths are packaged as 10F sheaths.
Code information: Lot #I2067768
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
Derived failure modes
-
Unknown
There is a potential that 7F sheaths are packaged as 10F sheaths.