Catheter cutdown trays recalled over damage to the outer tray
Bard Peripheral Vascular is recalling 14,935 Broviac 4.2 Fr single-lumen CV catheter cutdown trays because damage to the outer tray can potentially compromise the sterile barrier.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states tray damage can compromise the sterile barrier of a central venous catheter kit, and no injuries are reported.
Plain-English summary
The Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff, catalog number 60060, is being recalled by Bard Peripheral Vascular Inc.
The reason given in the enforcement record is damage to the outer tray that can potentially compromise the sterile barrier.
The record lists 14,935 units. Distribution was worldwide, including nationwide in the United States across the states listed in the enforcement record. The FDA has classified the action as Class II.
A compromised sterile barrier on a central venous catheter tray carries an infection risk. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Bard's instructions.
The recalled product
- Product
- Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Catheter tray
- Affected units
- 14,935
Distribution
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