FDA Medical Device Recalls (openFDA)
Busse Hospital Disposables: Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. 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.
- Recall number
- Z-0844-04
- Recalling firm
- Busse Hospital Disposables
- Product
- Suction Instrument with Tubing, Catalog No. 303. Instrument: Yankauer with Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. *Tubing Made in Mexico. 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.
- Status
- Terminated
- Initiated
- 2004-04-13
- Posted
- 2004-07-20
- Terminated
- 2005-02-18
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Barcode: *+H8003031U*. Lots: 0020337, 0020564, 0020577, 0020642, 0020897, 0020961, 0020986, 0021349, 0021367, 0021414, 0120065, 0120218, 0120394, 0121062, 0121169, 0121225, 0121414, 0220162, 0220213, 0220436, 0220510, 0220596, 0220970, 0221058, 0320169, 0320180, 0320205, 0320410, 0320660, 0321116, 0321180, 0321204.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EBR
- Firm FEI
- 2433012
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28