SafeStep Huber Needle Set myPICK Port Access Kit recall: Contamination
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI…
Why was SafeStep Huber Needle Set myPICK Port Access Kit recalled?
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695). Lot Numbers: REDZ0394 REDZ1664 REDZ3037 REEN1071 REER0578 REER1113 REEN0220 REEN0271 REEN5242 REEP2688 REDZ1486 REDZ1678 REEP1382 REER1973 Additional lot added 10/16/20: REEU0318
- Product
- SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI…
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 5,296,132 total
- Distribution
- Worldwide Distribution
- Recall date
- July 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)