FDA recall Z-0199-2018

Product

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

US Nationwide distribution in the states of GA, IN, FL, and PA

Key facts

Status

Terminated

Initiation date

2017-10-16

Report date

2017-12-13

Termination date

2020-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2018