Smiths Medical ASD Inc.: Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Recall number

Z-1543-2024

Recalling firm

Smiths Medical ASD Inc.

Product

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Status

Open, Classified

Initiated

2023-12-19

Posted

2024-04-15

Terminated

not on file

Reason

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Root cause

Process control

Action

Smiths Medical issued an Updated UREGNT MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2023 via US mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: "Customer Required Actions - Medfusion Infusion Pumps: 1. Locate any affected Medfusion Syringe Pumps that may be in your possession by referring to the list of affected devices included with the Response Form. This list includes any specific pump model/serial number(s) your organization purchased that were manufactured or serviced with potentially affected Barrel Clamp Guides. Each pump has a unique serial number found on the label on the bottom of the pump. 2. You may continue to use the pumps but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until pumps containing potentially affected Barrel Clamp Guides are repaired. Customer Required Actions - Individually Sold Barrel Clamp Guides: 1. Locate any affected Barrel Clamp Guide (Part Number G6000716) lots in your parts inventory or within the Medfusion Syringe Pump(s) you have repaired at your facility. NOTE - If you have purchased affected individually sold Barrel Clamp Guides, the Response Form included with this notice will indicate the order numbers shipped to your organization and a Return Label will be provided. 2. If any potentially affected Barrel Clamp Guides have already been installed in pumps, you may continue to use the pumps, but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until the pumps installed with potentially affected Barrel Clamp Guides are repaired. If you have affected devices, please contact Smiths Medical for repair of the pump." "DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Ask them to c

Quantity

1842 guide barrel clamps

Distribution

Worldwide distribution.

Lot, serial or model codes

Lot Numbers: P0407365, P0486670, P0561740

510(k) numbers

["K111386"]

PMA numbers

not on file

Product code

MRZ

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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