FDA Recall Open, Classified

Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

Recall: Z-2103-2020 · Initiated December 26, 2019

Recall

Recall Number
Z-2103-2020
Event Number
84656
Firm
Cardinal Health Inc.
FEI Number
3004008697
Product Code
LZH
Status
Open, Classified
Root Cause
Process control
Initiated
December 26, 2019
Address
7000 Cardinal Pl, Dublin, OH, 43017-1091

Description

Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100

Reason

The feeding spike sets may leak at the interface of the tube and spike connector.

Action

A Medical Device Product Advisory letter dated 12/23/19 was sent to customers. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize the equipment the risk of leaks at the interface of the tube and spike connector. 3) INSPECT the feeding set for leaks after the pump has been primed and the infusion has started. " If a leak is detected the feeding set must be discarded and a new feeding set must be obtained. Inspect the new feeding set for leaks in the same manner. 4) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product advisory. 5) RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email to [email protected], whether or not you have affected product. Please contact the Customer Service group for any questions related to this action: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

Distribution

Worldwide distribution.

Quantity

114,731, 290 total units