DeRoyal Head and Neck Surgical Kits Recalled for Damaged Syringe Luer Tip
DeRoyal Industries is recalling 32 surgical procedure kits containing syringes with potentially damaged luer tips that could compromise the sterile packaging barrier. The kits were distributed in Pennsylvania.
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 an FDA Class II recall for a risk-of-harm medical device product where no illnesses or injuries have been reported. The hazard—potential sterile barrier damage leading to contamination—is theoretical rather than confirmed.
Plain-English summary
DeRoyal Industries Inc is recalling 32 Head and Neck surgical procedure kits (REF 89-4473) that contain B.Braun Medical Norm-Ject 2 Piece Syringes. The affected kits have lot codes 59205650 and 59496207, both with expiration dates of November 1, 2027.
The recall was initiated because the sterile packaging barrier could potentially be damaged due to damage to the luer tip of the syringe. A compromised sterile barrier may allow bacterial or other contamination of the surgical instruments inside the kit.
The affected kits were distributed in Pennsylvania. Users who have received these kits should verify the lot code to determine if their kits are part of this recall.
The recalled product
- Product
- DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 32
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 (3)
- UDI/DI (GTIN) 74975659085
- Lot Codes: 59205650 exp 11/1/2027
- 59496207 exp 11/1/2027
Distribution
Distributed in 1 state:
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