DeRoyal Surgical Kits Recalled Due to Sterilant Exposure
DeRoyal Industries is recalling specific lots of sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during the sterilization process.
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: The recall involves a sterile medical device with a potential breach of sterility (unintended sterilant exposure). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DeRoyal Industries Inc is recalling specific lots of DeRoyal Sterile Custom Surgical Kits. These kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, and are identified by Lot Number 2016-09EE. The recall is being conducted because the product was exposed to the sterilant during the package sterilization process.
The affected products are sterile surgical kits intended for medical use. The specific hazard identified is unintended exposure to the sterilant, which occurred during the manufacturing sterilization phase. This exposure may compromise the safety or integrity of the sterile barrier or the solution within the kit.
Healthcare facilities and consumers who have these specific lots should stop using the product immediately. Users should contact DeRoyal Industries Inc for further instructions on how to return or dispose of the affected kits. The recall is limited to the specific catalog and lot numbers listed in the official notice.
The recalled product
- Product
- DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
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)
- REF 89-5720.04
- Lot Number 38322988
- REF 89-6717.03
- Lot Numbers: 38323059 and 38342436
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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