Z-0113-2018Class II

MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1...

Name: Z-0113-2018 MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1...
Creator: Medline Industries Inc
Published: 2017-10-10
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2017-10-10 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile on 2017-10-10. FDA classified it as Class II and gives the reason as "Products labeled as sterile were distributed prior to sterilization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0113-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2017-11-18
Terminated: 2020-08-04
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Products labeled as sterile were distributed prior to sterilization
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recall was initiated by mail on 10/10/2017. The letter contained the following directive: "REQUIRED ACTION: 1. Immediately check your stock for item numbers DYNCPE8 (Lot 2861707008) & DYNCSDS12 (Lot 28617070015) place them on hold and complete the attached response form. Quarantine all affected product / lots. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. If you have any questions, please contact 866-359-1704."
Quantity in commerce: 120 units
Distribution: FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras
Product codes and lots: Lot 28617070015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0113-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)