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

Recall Z-0784-2013 — THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using

U.S. FDA — Device Enforcement · United States · 2012-08-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0784-2013
Date of alert: 2012-08-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Lansinoh Laboratories Inc
Product category: device
Product type: Devices

Reported risk: The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.

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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