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Recall Observatory FDA recall evidence

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

August 05, 2014

Class II

Product summary

Firm
ICU Medical, Inc.
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

    reason.sterility_assurance · v1.0.0

    Sterile Field Saline Flush Syringe because some unit packages may exhibit open