BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The Bod
FDA device recall Z-1442-2020 · posted 2020-03-11 · Terminated
Recall details
- Recalling firm
- CME America, LLC
- Reason for recall
- When using a specific tubing set with infusion pump system, may result in under deliver of fluids.
- Action taken
- Updated 10/7/2019: On 09/16/2019, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via various methods (i.e., email, and written letter delivered by FedEx) along with a response form for customer acknowledgement. The notification informed customers, that all lots of its Microset tubing when used with their infusion pump system may under deliver fluids. The product was distributed beginning in October 2017. The firm is instructing customers to: 1. Immediately review their inventory for Catalog #A120-003XYVA and to discard all remaining inventory of the tube sets per their facility's guidelines 2. Share the Urgent Medical Device Recall notice with all users of the product with their facility to ensure awareness of this action. 3. Complete the attached Customer Response Form and return to the contact noted on the firm regardless of whether they have any affected material or not so that the Recalling Firm may acknowledge their receipt of the notification. Fax Number: 312-949-0333 or email to BDRC11@bd.comCustomer are to indicate on the response form the quantity of the tube sets remaining in inventory and confirm this inventory has been discarded. 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, Monday thru Friday from 9am to 5pm Mountain Time for a list of alternate sets that are available. Customer/Technical Support - 303-936-4545 or 877-263-0111 toll free.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 69400 infusion sets
- Distribution
- US: CA, OH, PA, and TX OUS: Canada
- Date initiated
- 2019-09-16
- Date posted
- 2020-03-11
- Date terminated
- 2022-04-13
- Location
- Golden, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BODYGUARD INFUSION PUMP SYSTEM (K042696) | Caesarea Medical Electronics , Ltd. | 2005-03-11 |