Z-1855-2022Class II

MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20...

Name: Z-1855-2022 MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-08-03
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-08-03 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as... on 2022-08-03. FDA classified it as Class II and gives the reason as "Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1855-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-03
Posted: 2022-09-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH DOUBLE SWIVEL, 16 Fr, Item Number/REF: DYNCPDS16
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process.
FDA root cause: Under Investigation by firm
Action: On about 08/03/2022, Medline notified consignees via first class mail letter of the recall. The letter instructed consignees to immediately review inventory and destroy all affected product and complete the response form indicated at the link provided in the letter. Distributors were instructed to notify customers if further distributed, instruct those customers destroy any affected product, and include customer quantities on response form.
Quantity in commerce: 65,320 units
Distribution: Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico. International distribution to Canada, Chile, Colombia, Panama, Qatar, United Arab Emirates
Product codes and lots: a. UDI-DI (GTIN) case: (01)20888277703367; UDI-DI (GTIN) Each: (01)10888277703360, Lot Number 6922040021; b. UDI-DI (GTIN) case: (01)20888277703381; UDI-DI (GTIN) Each: (01)10888277703384, Lot Numbers 6921050011, 6921070011, 6921070021, 6921060011, 6921060021, 6921080011, 6921100011, 6921100021, 6921120011, 6922010011, 6922020021, 6922030011; c. UDI-DI (GTIN) case: (01)20888277703404; UDI-DI (GTIN) Each: (01)10888277703407, Lot Number 6921120021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1855-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1855-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1856-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29
Z-1857-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)