| Date Initiated by Firm |
January 14, 2020 |
| Create Date |
May 04, 2020 |
| Recall Status1 |
Terminated 3 on May 27, 2021 |
| Recall Number |
Z-1886-2020 |
| Recall Event ID |
85206 |
| 510(K)Number |
K031749
|
| Product Classification |
Set, administration, intravascular - Product Code FPA
|
| Product |
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. |
| Code Information |
Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829 BodyGuard Microset 10818666020006 A120-112XSFK 16201 |
Recalling Firm/
Manufacturer |
CME America, LLC
14998 W 6th Ave Ste 830
Golden CO 80401-5025
|
| For Additional Information Contact |
303-936-4945
|
Manufacturer Reason
for Recall |
The filter installed onto the tube set may have the incorrect pore size.
|
FDA Determined
Cause 2 |
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 16201, the specified size on the label is 1.2 microns. A portion of the tube sets were incorrectly packaged and have a pore size of 0.2 microns rather than 1.2 microns.
Customer are instructed to take the following actions:
1. Immediately review their inventory for Catalog #A120-160XSFK/lot number 90829 and Catalog # A120-112XSFK/lot number 16201. Discard all remaining inventory of the tube sets per their facilitys guidelines.
2. Share this Urgent Medical Device Recall notice with all users of the product within their facility to ensure awareness of this action.
3. Complete the attached Customer Response Form and return it to the contact noted on the form regardless of whether you have any affected material or not so that we may acknowledge your receipt of this notification. Indicate on the response form the quantities of affected product remaining in inventory and confirm that this inventory has been discarded. Credit will be issued to customers for all discarded product.
4. Report any adverse health consequences experienced with the use of this product to the Recalling Firm.
5. Contact the Recalling Firm at 877-263-0111 (toll free) or 303-939-4545, Monday thru Friday from 9:00am to 5:00pm U.S. Mountain Time for a list of alternate sets that are available. |
| Quantity in Commerce |
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. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = FPA and Original Applicant = CAESAREA MEDICAL ELECTRONICS LTD.
|
