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.
Reported: August 27, 2014 Initiated: August 5, 2014 #Z-2295-2014
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 400 units
- Distribution
- Nationwide Distribution - USA including AL and MD.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ICU Medical, Inc.. Units affected: 400 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2295-2014.
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