Thera Pearl 3-in-1 Breast Therapy recall
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…
Why was Thera Pearl 3-in-1 Breast Therapy 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
- Product
- 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…
- Recalling firm
- Lansinoh Laboratories Inc
- Quantity
- 51,472 units
- Distribution
- Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
- Recall date
- February 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)