FDA-Device2017-12-13Class II
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f) Plastic Pack, REF 89-7212.04 g) Plastic Pack, REF 89-7212.05 Product Usage: Custom surgical and procedural kits
DeRoyal Industries Inc
Hazard
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Sold states
US Nationwide distribution in the states of GA, IN, FL, and PA
Affected count
5946 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f) Plastic Pack, REF 89-7212.04 g) Plastic Pack, REF 89-7212.05 Product Usage: Custom surgical and procedural kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2018Don't want to check this manually?
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