—#129173

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.

FDA product code: GAX — Tourniquet, Nonpneumatic
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot No. 2704633, 2705206

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: Nationwide Distribution - USA including AL and MD.

Timeline

Recall initiated: 2014-08-05
Posted by FDA: 2014-08-20
Terminated: 2015-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129173. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.