SafeStep Huber Needle Set with GuardIVa Antimicrobial recall: Contamination
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Why was SafeStep Huber Needle Set with GuardIVa Antimicrobial 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 Number CPA00040 (UDI 00801741143892). Lot Numbers: REEN0219 REEP1376 REEP3657
- Product
- SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
- 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)