BD Nexiva IV Catheter System Recalled for Septum Leak Risk
Becton Dickinson is recalling 6,720 units of BD Nexiva Dual Port 20GA IV Catheter Systems due to a potential leak that could expose health care workers to blood.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves a risk of blood exposure to health care workers, which aligns with the rubric criteria for Severe severity involving significant injury risks.
Plain-English summary
Becton Dickinson & Company is recalling 6,720 units of the BD Nexiva Dual Port 20GA 1.00IN Closed IV Catheter System, Catalog Number 383536. The affected units are identified by Lot Number 8337721, with an expiration date of 30-Nov-2021 and UDI 382903835362. The product is intended for use in the peripheral vascular system.
The recall was initiated because a leak from the septum assembly or the canister may burst under high pressure. This defect could result in blood exposure to a health care worker. The agency has classified this as a Class II recall.
The affected units were distributed in the United States to one distributor in Virginia. Health care facilities and distributors should stop using the affected devices and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — IV Catheter
- Hazard
- Affected units
- 6,720
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 (1)
- Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362
Distribution
Distributed in 1 state:
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