DeRoyal Recalls Sterile Surgical Kits Due to Sterilant Exposure
DeRoyal Industries is recalling 355 sterile surgical kits containing 3M DuraPrep solution due to unintended exposure to sterilant during package sterilization.
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 surgical kits) where unintended exposure to sterilant could cause injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
DeRoyal Industries Inc is recalling 355 units of DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot No. 2016-09EE. The recall was initiated because the products were exposed to the sterilant during the package sterilization process.
The affected products include various surgical trays and packs, such as Total Knee, Total Hip, Podiatry, Knee Scope, Knee, Beach Chair, Total Joint, Back, and Pacemaker packs. The specific reference numbers and lot numbers for these items are listed in the agency's recall documentation.
The products were distributed to facilities in South Carolina, Florida, Ohio, New Jersey, Oklahoma, Minnesota, and Arkansas. Healthcare facilities should stop using the affected kits and contact DeRoyal Industries for further instructions.
The recalled product
- Product
- DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF…
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 355
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 (19)
- REF 89-4561.11
- Lot numbers: 38198163
- 38276045
- REF 89-4562.12
- Lot Number 38345071
- REF 89-3101.04
- Lot Number 38276230
- REF 89-7744.03
- Lot Number 38229177
- REF 89-8194.02
- Lot Number 38245020
- REF 89-8439.01
- Lot Number 38317548
- REF 50-12160.17
- Lot Number 38247391
- REF 50-12602.09
- Lot Number 38345266
- REF 89-8381.01
- Lot Number 38085071
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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