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

Recall Z-0085-2018 — 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

U.S. FDA — Device Enforcement · United States · 2017-10-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0085-2018
Date of alert: 2017-10-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bioseal Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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