Medical device recalls High risk

Centurion Medical Products Corporation recalls Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in pat…

Recall date
October 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0647-2017
FDA classification
Class I
Brand / firm
Centurion Medical Products Corporation
Sold / distributed
Nationwide Distribution

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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