Recall Z-2328-2012 ยท LRP Tray, Surgical
Custom Medical Specialties, Inc.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
| Date | Sep 7, 2012 (initiated Sep 30, 2011) |
| Status | Terminated |
| Reason | The firm saw on the FDA web site a recall by the manufacturer due to no microbial testing in place at the manufacturer and product did not meet proper finished goods specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Custom Medical Specialties sent an Urgent Medical Device Recall letter dated August 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory for the affected product and to discontinue the use of any affected product. Customer were instructedto complete and return the Return Response form, acknowledging they have received the letter and checked their inventory. Any product still in the customers inventory should be returned to the firm. Customers should call (91 |
| Quantity | 3 cases |
| Distribution | Nationwide Distribution including GA, MI, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.