Class 2 Device Recall Bioseal Trachea Extender

• Date Initiated by Firm: August 15, 2019
• Create Date: August 13, 2020
• Recall Status: Terminated on March 04, 2021
• Recall Number: Z-2795-2020
• Recall Event ID: 85288
• Product Classification: Connector, airway (extension) - Product Code BZA
• 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.
• Code Information: Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476
• Recalling Firm/ Manufacturer: Bioseal Corporation; 167 W Orangethorpe Ave; Placentia CA 92870-6922
• For Additional Information Contact: Tina Nine; 714-924-7278
• Manufacturer 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.
• FDA Determined 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 recalls@biosealnet.com. 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.