—#99619

Product

MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K051499
Affected lot / code info: Lot Numbers: 10128001, 11018001, 11018002, 11018003, 11018007, 11018012, 11018013.

Why it was recalled

Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.

Root cause (FDA determination)

Device Design

Action the firm took

CareFusion initiated on May 3, 2011, two distinctive "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned. 2.) All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods number through their distributor or CareFusion. 3.) Also, enclosed is a Frequently Asked Question (FAQ) Letter to address any questions or concerns related to the use of the MaxPlus" bifuse extension sets. The second notification was specifically addressed to distributors. The distributors were provided specific instructions for product returned. For customers who may have questions, please contact your distributor directly, or call the CareFusion Support Center at 1-800- 562-6018. The Support Center will be in operation from 7 a.m. - 4 p.m. PST. For distributors who may have any questions or require additional materials, please contact the CareFusion Support Center at 1800- 562-6018. Additionally, instructions were given to report adverse reactions experienced via the FDA's Med Watch Program.

Recalling firm

Firm: Carefusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Nationwide Distribution -- USA including states of: CA, IA, IN, and TX

Timeline

Recall initiated: 2011-04-20
Posted by FDA: 2011-06-29
Terminated: 2011-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99619. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.