FDA-Device2014-08-27Class II
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.
ICU Medical, Inc.
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.
Sold states
Nationwide Distribution - USA including AL and MD.
Affected count
400 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2295-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief