Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
FDA Recall Z-2104-2020 · Posted None
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Recalling FirmCardinal Health Inc.
Recall StatusOpen, Classified
Product CodeLZH
Date Initiated2019-12-26
Product Quantity114,731, 290 total units
Reason for Recall
The feeding spike sets may leak at the interface of the tube and spike connector.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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