Recall Z-0202-2023 ยท LJH System, Irrigation, Urological
Canadian Hospital Specialties
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
| Date | Nov 11, 2022 (initiated Aug 19, 2022) |
| Status | Terminated |
| Reason | Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package. |
| Root cause | Nonconforming Material/Component |
| Action | The firm issued a MEDICAL DEVICE RECALL NOTICE to its consignees on 08/23/2022 by email. The notice explained the issue and requested the following: "TO IMPLEMENT THIS RECALL, PLEASE PERFORM THE FOLLOWING ACTIONS: 1.Examine your stock and determine if you have any affected product and lot. 2.Complete the attached Product Recall Response Form and send torecalls@chsltd.com. 3.Please report any affected units of the product to CHS for further instructions." For questions, contact: recalls @chsltd.com |
| Quantity | 9100 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 Benlan, Inc., Nov 28, 2001 |