Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
FDA Recall Z-0647-2017 · Posted 2016-12-02
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Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeFOZ
Date Initiated2016-10-21
Date Terminated2017-07-20
Product Quantity1000 kits
Reason for Recall
The kits contain Multi-Med Single Lumen Catheters that
have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It
is possible that the excess material may separate from the catheter during use and pose a potential risk
of embolism, which could result in serious injury or death.
Firm Action
Centurion sent an Urgent Recall Notice dated October 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356.
For questions regarding this recall call 517-546-5400.
Root Cause
Process control
Distribution Pattern
Nationwide 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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