CAP Change Kit w/MicroClave Clear, Item No. B78109 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.
Recall
- Recall Number
- Z-2293-2014
- Event Number
- 68973
- Firm
- ICU Medical, Inc.
- FEI Number
- 2025816
- Product Code
- GAX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 5, 2014
- Posted
- August 20, 2014
- Terminated
- February 26, 2015
- Address
- 951 Calle, Amanecer San Clemente, CA, 92673-6212
Description
CAP Change Kit w/MicroClave Clear, Item No. B78109 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 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.
An Urgent recall letter dated 8/5/2014 was sent to all customers who purchased the BD PosiFlush SF Saline Flush Syringe 10ml. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact ICU Customer Service Monday through Friday between 8:30AM to 4:00PM PST at (866) 829-9025 and select option 8, or email [email protected]. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or email to [email protected].
Nationwide Distribution - USA including AL and MD.
300 units