Z-2795-2020Class II

Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of...

Name: Z-2795-2020 Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of...
Creator: Bioseal Corporation
Published: 2019-08-15
License: https://open.fda.gov/license/

Bioseal / initiated 2019-08-15 / Terminated / root cause: design

FDA source

Bioseal Corporation began a recall of Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01)... on 2019-08-15. FDA classified it as Class II and gives the reason as "The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2795-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-15
Posted: 2020-08-13
Terminated: 2021-03-04
Recalling firm: Bioseal
Product: Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
Product code: BZA Connector, Airway (Extension)
Reason for recall: The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 8/15/2019, the firm sent an "Urgent: Medical Device Recall" letter via email followed up by phone calls to its customers to inform them the firm is voluntarily recalling product that has been affected by an urgent medical device recall from Intersurgical, Inc. There appears to be a potential portal crack with the Swivel Elbow component where the flip cap is inserted. It seems these cracks could possibly leak if they reach a significant size that may pose a serious health risk to the patient. The reported stress crack could result in leakage from the breathing system allowing the prescribed ventilation not being delivered to the patient. The firm is instructing customers to review their records if they have received the affected part (TRAX01/50) and its associated lots being recalled by Intersurgical, Inc. Please discontinue use of the product and complete the response form listing the quantity of affected product on hand via email to [email protected]. Negative response is also requested when completing the form. Once the competed form are received the firm will forward product return information, if applicable. If the affected product has been transferred to another individual, another department or another location in your organization, you are required by FDA regulations to notify them of this recall communication. Any questions regarding this matter, please contact customer service at 800-441-7325, Monday - Friday, 8am - 5pm PST. Adverse reactions or quality problem experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program.
Quantity in commerce: 900 units
Distribution: US Nationwide distribution including in the state of CA.
Product codes and lots: Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2795-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2795-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code BZA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)