Recall Z-0115-2024— Access Vascular, Inc
Class II · Ongoing
Class II FDA medical device recall by Access Vascular, Inc, initiated 2023-08-31. It names one FDA 510(k) clearance: K213550. Product: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004. Reason: Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date..
- Recalling firm
- Access Vascular, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-31
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Reason for recall
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.