Device product
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Z-2295-2014
Product summary
- Event
- Event 68973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 400 units
- Official record key
device-enforcement:Z-2295-2014
Official wording
Reason: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Code information: Lot No. 2705203
Distribution pattern: Nationwide Distribution - USA including AL and MD.
Derived failure modes
-
Sterility assurance
Sterile Field Saline Flush Syringe because some unit packages may exhibit open