Device product
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Z-0504-2020
Product summary
- Event
- Event 83907
- Status
- Terminated
- Classification
- Class II
- Quantity
- 582
- Official record key
device-enforcement:Z-0504-2020
Official wording
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
Code information: 5478033, 5482424
Distribution pattern: Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada.
Derived failure modes
-
Potency or specification failure
may not meet dimensional specifications