Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 Tra — recall Z-0199-2018

U.S. FDA — Device Enforcement · United States · 2017-10-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0199-2018
Date of alert: 2017-10-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DeRoyal Industries Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 42728139

Reported risk: Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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