Recall Z-1036-2016 ยท FRO Dressing, Wound, Drug
Medical Action Industries Inc
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings
| Date | Feb 3, 2016 |
| Status | Terminated |
| Reason | Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling |
| Root cause | Under Investigation by firm |
| Action | Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@ |
| Quantity | 9 cases (180 kits) |
| Distribution | Nationwide distribution to MO, NE and TX . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.