MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
FDA device recall Z-0202-2023 · posted 2022-11-11 · Terminated
Recall details
- Recalling firm
- Canadian Hospital Specialties
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LJH
- Quantity affected
- 9100 units
- Distribution
- US
- Date initiated
- 2022-08-19
- Date posted
- 2022-11-11
- Date terminated
- 2023-03-20
- Location
- Oakville, Canada
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (K010607) | Benlan, Inc. | 2001-11-28 |