FDA recall Z-0085-2018

Product

Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

Reason for recall

Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

Distribution

CA, IL, NC, VT

Key facts

Status

Completed

Initiation date

2017-10-18

Report date

2017-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Placentia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2018