Reported Aug 19, 2020 · Terminated
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX,…
Bioseal Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bioseal Corporation · 167 W Orangethorpe Ave · Placentia, CA · 92870-6922
Is this the product you have?
- 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 UsageAirway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask
- Lot codes and dates
- Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476
- Amount recalled
- 900 units
Where it was sold
- Nationwide
- CA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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