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BodyGuard Microset with Filter recallZ-1886-2020 · CME America, LLC · initiated Jan 14, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CME America, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The filter installed onto the tube set may have the incorrect pore size.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1886-2020
Status
Terminated
Initiated by the company
Jan 14, 2020
Recalling firm
CME America, LLC
Quantity
5,800 infusion sets from lot 90829 and 24,500 from lot 16201
Product code
FPA
FDA submissions
K031749
Distribution
US Nationwide distribution including in the states of AK, CA, IL, KS, MA, MO, and SD. No O.U.S.

Product description

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 (models, lots, serial numbers)

Product Name UDI Catalog No. Lot No. BodyGuard Microset 10818666020013 A120-160XSFK 90829  BodyGuard Microset 10818666020006 A120-112XSFK 16201

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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