Recall Z-0845-04 ยท EBR Unit, Suction Operatory
Busse Hospital Disposables
Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. busse Hospital Disposables Hauppauge, NY 11788. --- Classification Name: Unit, Suction Operatory. Class I device, 510 (k) exempt, Device Listing Number A715729. Product comprises 2 components: a Yankauer made from K-Resin and tub
| Date | Jul 20, 2004 (initiated Apr 13, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Urgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.