DeRoyal recalls two custom surgical kits with potential sterility defect
DeRoyal Industries Inc is recalling two custom surgical kits containing a BARD Toomey Irrigation Syringe due to a possible package slit that may affect sterility.
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: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
DeRoyal Industries Inc is recalling two custom surgical kits, identified as DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08. These kits contain the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The specific lot number for the recalled items is 40004006.
The recall is being conducted because of a possible slit defect on the package of the BARD(TM) component. This defect may affect the component's sterility. The source text does not report any illnesses or injuries associated with this defect.
The affected units were distributed in Louisiana and Tennessee. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 24
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 40004006
Distribution
Part of a larger recall action
This product is one of 2 recalled by DeRoyal Industries 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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