Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ

FDA device recall Z-1876-2024 · posted 2024-05-28 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

Action taken

The recalling firm issued letters via email and first class mail on 2/26/2024. The recall letter informed the customer the recall was being conducted for specific items and lots of SubG Endotracheal Tube with Subglottic Suction due to receiving complaints that the inflation tube detached and/or tore from the main tube. There had also been reports indicating the suction pump is difficult to connect or detaches during use. The potential product impact was also provided. Affected product could be destroyed for credit and no product was to be returned. Required actions were provided: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. The link to the recall portal was provided. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form. The letter provided a link to their recall portal to access the response form for completion and view the specific products distributed to the respective customers. If the consignee is a distributor or has resold or transferred the product to another company or individual, they are to contact them and notify them of this recall communication and request they document and destroy any affected product and include the customer quantities in the distributor response form. The recalling firm issued a second recall letter dated 3/19/2024. The letter informed the consignee that the recalling firm was issuing a recall for specific items and lots of SubG Endotracheal Tube with Subglottic Suction with Medline Kits. If the consignee has the affected kits, they are to indicate the quantity

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BTR

Quantity affected

168,632 tubes and 13,092 kits

Distribution

Distribution was nationwide. There was government/military distributon. Foreign distribution was made to San Salvador and United Arab Emirates.

Date initiated

2024-02-26

Date posted

2024-05-28

Location

Northfield, IL

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