CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and

FDA device recall Z-2293-2014 · posted 2014-08-20 · Terminated

Recall details

Recalling firm

ICU Medical, Inc.

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.

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.

Root cause

Other

Status

Terminated

Product code

GAX

Quantity affected

300 units

Distribution

Nationwide Distribution - USA including AL and MD.

Date initiated

2014-08-05

Date posted

2014-08-20

Date terminated

2015-02-26

Location

San Clemente, CA