DeRoyal recalls custom sterile surgical packs with Terumo valve defect
DeRoyal Industries Inc is recalling 181 custom sterile surgical packs distributed in New York due to a Terumo valve defect causing no flow.
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 medical device with a functional defect ('No Flow') that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
DeRoyal Industries Inc is recalling 181 units of custom sterile surgical packs labeled as GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO, intended for use in shoulder arthroscopy. The affected products are identified by lot numbers 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, and 46203903.
The recall was initiated because the surgical kits contain a Terumo Over Pressure Safety Valve that was subsequently recalled by Terumo CVS due to reports of 'No Flow' through the valve. This defect may prevent the proper function of the safety mechanism during use.
The affected products were distributed in New York. Healthcare facilities and consumers who have these specific surgical packs should stop using them and contact DeRoyal Industries Inc or their supplier for instructions on return or replacement.
The recalled product
- Product
- Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 181
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 (7)
- Lot numbers: 43097391
- 43685581
- 44750305
- 45377442
- 45464669
- 45698684
- 46203903
Distribution
Distributed in 1 state:
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