Z-0199-2018 Class II Terminated
FDA device recall Z-0199-2018 was initiated by DeRoyal Industries Inc on October 16, 2017 and is designated Class II. Reason for recall: Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date. The recall status is terminated (terminated August 21, 2020). Affected quantity: 5946 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2017
- Initiation Date
- October 16, 2017
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5946 units
Product Description
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
Reason for Recall
Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.
Distribution Pattern
US Nationwide distribution in the states of GA, IN, FL, and PA
Code Information
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