Recall Z-1301-2015 ยท IMD Pack, Hot Or Cold, Disposable
CooperSurgical, Inc.
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
| Date | Mar 19, 2015 (initiated Jan 26, 2015) |
| Status | Terminated |
| Reason | Products without expiration date have the remote potential for minor burn |
| Root cause | Package design/selection |
| Action | CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. |
| Quantity | 4938266 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912715 | INSTANT WARM GEL PACK Prism Technologies, Inc., Oct 2, 1991 |