Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Incorrect instructions for use (IFU)."
Plain-English summary
Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Product Code 631-500. The recall is being conducted because the product contains incorrect instructions for use (IFU). The system is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico), as well as to Costa Rica and Russia. The recall covers all lot codes. No specific illnesses or injuries are reported in the source text.
Healthcare providers and facilities should stop using the affected TRUFILL n-BCA Liquid Embolic System units and contact Codman & Shurtleff, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 7,983
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)
- All lot codes
Distribution
Part of a larger recall action
This product is one of 2 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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