FDAFDA · Food and drugs·Recall number Z-0199-2018
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
Published December 13, 2017 · Recall initiated: October 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US Nationwide distribution in the states of GA, IN, FL, and PA
- Lot
- a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.