Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductiv
FDA device recall Z-0844-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Busse Hospital Disposables
- Reason for recall
- Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
- Action taken
- Urgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- EBR
- Distribution
- Distributors and end users (hospitals, fire departments/EMS) located nationwide, in Puerto Rico, St. Thomas, Canada, Dominican Republic, Panama, Uganda, Dubai, and Abu Dhabi, United Arab Emirates.
- Date initiated
- 2004-04-13
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-18
- Location
- Hauppauge, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.