MedComp Recalls DUO FLOW Custom Trays Due to Suture Wing Cracking
Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays because suture wings may crack or break, posing risks of catheter dislocation, bleeding, and air emboli.
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 involves a medical device defect with potential for significant injury (bleeding, air emboli, catheter dislocation), which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects, despite the absence of reported serious injuries to date.
Plain-English summary
Medical Components, Inc dba MedComp is recalling DUO FLOW Custom Trays (Tray #414, Tray #415, and Tray #67) due to a potential defect in the suture wings. The suture wings have the potential to crack or break during use.
The recall is being conducted because the malfunction of these suture wings could lead to patient injury, including catheter dislocation, bleeding, and air emboli. The firm has received six complaints regarding malfunction, involving 29 broken suture wings, to date. No serious injuries or deaths have been reported in connection with these complaints.
The affected products were distributed nationwide and worldwide. Healthcare providers and consumers should stop using these specific trays and contact the recalling firm for further instructions or replacement.
The recalled product
- Product
- DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Surgical Trays
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medical Components, Inc dba MedComp 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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