Reported Feb 28, 2018 · Terminated
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use:…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- Custom sterile
- surgical packs labeled as followsGEO-MED CABG PACK PGYBK A & B, REF 89-5985.07
- STERILE EO UseShoulder Arthroscopy
- Lot codes and dates
- Lot numbers
43097391436855814475030545377442454646694569868446203903
- Lot numbers
- Amount recalled
- 181 units
Where it was sold
Why it was recalled
DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
This product could cause temporary or reversible health problems — stop using it.
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