Recall Z-2295-2014 ยท GAX Tourniquet, Nonpneumatic
ICU Medical, Inc.
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.
| Date | Aug 20, 2014 (initiated Aug 5, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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 customerservice@icumed.com. Customers are instructed to complete the attached Medical Device Recall Response Form and fax to (801) 264-1755 or email to recall@icumed.com. |
| Quantity | 400 units |
| Distribution | Nationwide Distribution - USA including AL and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.