Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646
FDA device recall Z-1299-2015 · posted 2015-03-19 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Products without expiration date have the remote potential for minor burn
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- IMD
- Quantity affected
- 8865584 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.
- Date initiated
- 2015-01-26
- Date posted
- 2015-03-19
- Date terminated
- 2016-06-14
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTANT WARM GEL PACK (K912715) | Prism Technologies, Inc. | 1991-10-02 |