—#113585

Product

3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K914299
Affected lot / code info: Part Number (Item #) AG8049-NS, Lot # 2528655.

Why it was recalled

ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

ICU Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated September 28, 2012 to its customer. The letter identified the product, problem, and actions to be taken by the customer. The customer has been instructed to inspect their inventory for the specific lot numbers, examine for the presence of a metal cannula, and certify destruction of any affected devices. The customer letter included a Verification Form to be completed and returned. Contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com" for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution: Virginia only.

Timeline

Recall initiated: 2012-09-28
Posted by FDA: 2012-10-11
Terminated: 2013-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.