FDAFDA · Food and drugs·Recall number Z-2294-2014
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 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.
Published August 27, 2014 · Recall initiated: August 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Nationwide Distribution - USA including AL and MD.
- Lot
- Lot No. 2705219
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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