DeRoyal Recalls Custom Surgical Kits with Defective Medtronic Gloves
DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.
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 medical device defect (splits or holes in gloves) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
DeRoyal Industries Inc is recalling custom surgical kits that contain Medtronic Covidien Devon Light Gloves. The recall is being conducted because the gloves were found to have splits or holes.
The affected products include various surgical trays and packs, such as the Angio Tray, Neuro Spine Tray, and Major Procedure Tracecart. A total of 235,785 units are involved in this recall.
The products were distributed nationwide in the United States and in Guatemala. Healthcare facilities and consumers should stop using these specific kits and contact DeRoyal Industries for further instructions.
The recalled product
- Product
- Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-347
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 235,785
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 (20)
- REF 50-12127: Lot numbers: 36207249
- 36396502
- 36912175
- 38441725
- REF 53-1931: Lot numbers: 33718713
- 34910141
- 34939139
- 35588220
- 35814688
- 35850671
- 35850689
- 35862524
- 36047791
- 36095291
- 36517319
- 36746146
- 36753451
- 37137174
- 36917953
- 37581806
Distribution
Distributed nationwide across the United States.
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