Recall Z-0090-2018 ยท FRN Pump, Infusion
WalkMed, LLC
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part Number 204821 Catalog Number IPR-150/10 150 mL The WalkMed Reservoir Bag is designed for use with the WalkMed 350VL Ambulatory pump and is intended to be used as a reservoir and fluid path for administering intravenous, subcutaneous, arterial, enteral, and epi
| Date | Sep 27, 2017 |
| Status | Terminated |
| Reason | There have been reported incidents of fluid leaks at the luer connection. Leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter. |
| Root cause | Process control |
| Action | WalkMed sent an Urgent Medical Device Recall letter dated September 27, 2017, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: discontinue distribution of any affected products. Contact any customers to whom these products were dispensed and inform the customers accordingly based on the following items. Wear gloves and other personal protective equipment as needed to avoid contact with leaking infusion fluids when handling the product. Collect and return affected products using proper bioha |
| Quantity | 25,920 bags |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K870524 | AMBULATORY INFUSION PUMP DRUG RESERVOIR Med Fusion Systems, Inc., May 6, 1987 |