Reported Feb 13, 2013 · Terminated
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…
Lansinoh Laboratories Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lansinoh Laboratories Inc · 333 N Fairfax St Ste 400 · Alexandria, VA · 22314-2632
Is this the product you have?
- 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 a breast pump.
- Lot codes and dates
Lot Numbers 100/12/01116/12/01108/12/01109/12/01149/12/01
- Amount recalled
- 51,472 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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