Recall Z-2293-2014
ICU Medical, Inc. · initiated August 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot No. 2704633, 2705206
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2293-2014
- Initiated
- August 5, 2014
- Posted by FDA
- August 20, 2014
- Terminated
- February 26, 2015
- Product code
- GAX – Tourniquet, Nonpneumatic
- Quantity
- 300 units
- Distribution
- Nationwide Distribution - USA including AL and MD.
- Recalling firm
- ICU Medical, Inc., San Clemente, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2294-2014 Class II | Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes…ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may… | 08/05/2014Terminated |
| Z-2295-2014 Class II | Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes…ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may… | 08/05/2014Terminated |