DeRoyal Recalls Custom Surgical Kits Due to Sterility Concerns
DeRoyal Industries is recalling 26 custom surgical kits containing Bard Toomey Irrigation Syringes due to a possible package defect 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 (sterility defect in a surgical kit) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DeRoyal Industries Inc. is recalling 26 units of Geo-Med TURP/CYSTO PACK PGYBK custom surgical kits. These kits contain the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter, and Cap. The specific lot number is 40259236.
The recall was initiated because of a possible slit defect on the package of the BARD(TM) component. This defect may affect the component's sterility. The affected units were distributed in Louisiana and Tennessee.
Healthcare providers and facilities that have received these kits should stop using them and contact DeRoyal Industries Inc. for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 26
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 40259236
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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