Recall Z-0511-2025
MEDLINE INDUSTRIES, LP - Northfield · initiated October 16, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A
Codes / lots: Codes: 1) DYNJRA9043S, UDI/DI 10193489888287(each) 40193489888288(case), Lot Numbers: 23CBE390, 23CBO216, 23EBM309, 23EBP979, 23EBS281, 23GBV099, 23HBG915, 23IBG610, 23IBG611, 23JBQ712, 23KBC341; 2) PAIN1622A, UDI/DI 10193489891690 (each) 40193489891691 (case), Lot Numbers: 21ELA821, 21GLA615, 21KLA308, 22ALA608, 22CLA681, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896
Reason for recall
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
FDA-determined cause: Under Investigation by firm
Action taken
An IMMEDIATE ACTION REQUIRED RECALL notification letter dated 10/16/24 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form, your account will receive over-labels to place unaffected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-24-216-FGRecall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-0511-2025
- Initiated
- October 16, 2024
- Posted by FDA
- November 22, 2024
- Product code
- OGJ – Nerve Block Tray
- Quantity
- 3396 units
- Distribution
- US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0508-2025 Class II | MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter ConnectorThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0509-2025 Class II | MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0510-2025 Class II | MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0512-2025 Class II | MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0513-2025 Class II | MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2)…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0514-2025 Class II | MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876AThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |
| Z-0515-2025 Class II | MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF…The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open… | 10/16/2024Open, Classified |