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.
What this means for you
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
- Hazard
- sterility-compromise
- contamination-risk
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.
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