Recall Z-1886-2020 ยท FPA Set, Administration, Intravascular
CME America, LLC
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
| Date | Jan 14, 2020 |
| Status | Terminated |
| Reason | The filter installed onto the tube set may have the incorrect pore size. |
| Root cause | Process control |
| Action | On 12/20/2019, the firm contacted its distributors via phone call to request that the affected lots not be further distributed pending the Recalling Firm's investigation and assessment for recall. On 01/15/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification to customers via email and FedEx informing them that the filter installed onto the tube set may have the incorrect pore size: -For the lot 90829, the specified size on the label is 0.2 microns. A portion of the tube sets were incorrectly packaged and have a pore size of 1.2 microns rather than 0.2 microns. -For the lot 162 |
| Quantity | 5,800 infusion sets from lot 90829 and 24,500 from lot 16201 |
| Distribution | US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031749 | BODYGUARD INFUSION SYSTEM Caesarea Medical Electronics , Ltd., Aug 21, 2003 |