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

Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile enviro — recall Z-1903-2017

U.S. FDA — Device Enforcement · United States · 2017-03-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1903-2017
Date of alert: 2017-03-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Breg Inc
Product category: device
Product type: Devices

Reported risk: They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.

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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