Recall Z-0784-2013— Lansinoh Laboratories Inc
Class II · Terminated
Class II FDA medical device recall by Lansinoh Laboratories Inc, initiated 2012-08-14, terminated 2013-03-08. FDA's recall record names no specific 510(k) clearance for this event. 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 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.. Reason: 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..
- Recalling firm
- Lansinoh Laboratories Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-14
- Terminated
- 2013-03-08
- Firm location
- Alexandria, VA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.