Recall Z-2147-2023 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
Cardinal Health 200, LLC
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
| Date | Jul 17, 2023 (initiated Jun 16, 2023) |
| Status | Open, Classified |
| Reason | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape. |
| Root cause | Process control |
| Action | Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 06/16/2023 for delivery n 06/19/2023 by FedEx priority overnight. The notice explained the problem, risks, and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product code and lot. Location of product code and lot are shown in above listed table and below example labeling. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to |
| Quantity | 44,500 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961154 | BAXTER SODIUM ACETATE INFANT HEEL WARMER Baxter Healthcare Corp, Jun 6, 1996 |