Custom Medical Procedure Packs Recalled for Compromised Package Seals
DeRoyal Industries is recalling 40 units of STURDI STRAINER TRAY STANDARD procedure packs nationwide due to potentially compromised outer package seals that could 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: This is a Class II FDA medical device recall without reported hospitalizations, injuries, or illnesses. The hazard presents a potential risk of serious harm from compromised sterility in medical use, but no actual injury has been reported, placing it at severity level 3 per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc is recalling STURDI STRAINER TRAY STANDARD custom medical procedure packs (Reference number 89-5014) due to a packaging defect. Approximately 40 units were distributed nationwide.
The outer package seal could be open or compromised, which affects the sterility assurance of the procedure pack inside. Compromised package integrity can lead to contamination or infection if the affected packs are used in medical procedures.
Healthcare facilities and individuals who received this product should immediately stop using any affected packs and contact the manufacturer for guidance on return or replacement.
The recalled product
- Product
- Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Procedure Packs
- Affected units
- 40
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 (4)
- a) REF '89-5014
- GTIN 50749756217908 (cs)
- 00749756217903 (unit)
- Lot Numbers: 58770294
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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.
See all 5 products in this recall →Related recalls
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