Z-0845-04

Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4''...

Name: Z-0845-04 Suction Instrument with Tubing, Catalog No. 305. Instrument: Yankauer without Vent. *Tubing: 10'' x 1/4''...
Creator: Busse Hospital Disposables
Published: 2004-04-13
License: https://open.fda.gov/license/

Busse Hospital Disposables / initiated 2004-04-13 / Terminated

FDA source

Busse Hospital Disposables began a recall of 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... on 2004-04-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0845-04
Status: Terminated
Initiated: 2004-04-13
Posted: 2004-07-20
Terminated: 2005-02-18
Recalling firm: Busse Hospital Disposables
Product: 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 tubing made from PVC. Each instrument is packed in a flexible packaging comprising Tyvek(R) and plastic film. There are 20 units per shipping carton.
Product code: EBR Unit, Suction Operatory
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.
FDA 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.
Product codes and lots: Barcode: *+H8003051W*. Lots: 0020491, 0020510, 0020607, 0021386, 0120147, 0120211, 0120265, 0120377, 0120585, 0120904, 0121194, 0121312, 0220006, 0220200, 0220302, 0220550, 0220779, 0220925, 0221006, 0320104, 0320179, 0320230, 0320408, 0320556, 0320680, 0320973.

Product code EBR

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)