Recall Z-0617-2025 ยท NAC Dressing, Wound, Hydrophilic
Advanced Medical Solutions Ltd.
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: pressure ulcers leg ulcers cavity wounds lacerations post-operative surgical wounds
| Date | Dec 4, 2024 (initiated Oct 1, 2024) |
| Status | Open, Classified |
| Reason | Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier. |
| Root cause | Packaging process control |
| Action | On 10/22/2024, the firm emailed a "Field Corrective Action - Field Notice" to customers. On 11/19/2024, an "URGENT: MEDICAL DEVICE RECALL" Letter was distributed via email to affected customers informing them that the firm has become aware of defects on primary packaging pouches, in which minor missing patches of Polyethylene have been detected. These defects could compromise the device's ability to maintain a sterile barrier. Customers are instructed: Distributor/Logistic Centers - 1. Stop/cease distribution of affected products. Immediately inspect internal inventory for the aforemention |
| Quantity | 3900 boxes |
| Distribution | U.S. Nationwide distribution in the states of IL, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.