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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Catheters
- 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.
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