The Recall Desk
SevereFDA (Devices)·Z-0647-2017·Announced 2016-12-14

Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the defect could result in serious injury or death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.

Plain-English summary

Centurion Medical Products Corporation is recalling 1,000 Multi-Med Single Lumen Catheters sold in Centurion convenience kits. These catheters are indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring. The affected products were distributed nationwide.

The recall is due to a manufacturing defect where excess material may remain at the tip of the catheter. This material has the potential to separate from the catheter during use, posing a risk of embolism, which could result in serious injury or death.

Healthcare facilities and consumers should stop using the affected kits immediately. The recall covers specific kit codes and lot numbers, including ECVC1680, ECVC4785, M11620HKIC, M11620HKICNL, M11620HS, M11620KC, M11620KCNL, M12013K, and M12013KNL. Users should check their inventory against the specific lot numbers listed in the official recall notice to identify affected units.

The recalled product

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.
Affected units
1,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 16G
  • 20G
  • 13cm) Lot numbers 2016072950 2016082450

Distribution

Distributed nationwide across the United States.