Recall Z-0647-2017— Centurion Medical Products Corporation
Class I · Terminated
Class I FDA medical device recall by Centurion Medical Products Corporation, initiated 2016-10-21, terminated 2017-07-20. It names one FDA 510(k) clearance: K955839. Product: 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.. Reason: 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..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2016-10-21
- Terminated
- 2017-07-20
- Firm location
- Williamston, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.