FDA Medical Device Recalls (openFDA)
Busse Hospital Disposables: Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *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-0843-04
- Recalling firm
- Busse Hospital Disposables
- Product
- Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1/4'' I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx ONLY. Packaged and Sterilized in the U.S.A. *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: * +H8003021T*. Lots: 0020404, 0020421, 0020539, 0020567, 0020578, 0020578, 0020641, 0020933, 0020982, 0021060, 0021067, 0021262, 0021366, 0022027, 0120089, 0120146, 0120217, 0120285, 0120342, 0120427, 0120491, 0120626, 0120697, 0120753, 0120866, 0120968, 0121063, 0121172, 0121403, 0220079, 0220201, 0220305, 0220348, 0220424, 0220474, 0220509, 0220522, 0220673, 0220683, 0220847, 0220927, 0220956, 0320185, 0320194, 0320208, 0320243, 0320267, 0320335, 0320343, 0320391, 0320392, 0320412, 0320438, 0320438, 0320485, 0320504, 0320536, 0320558, 0320582, 0320609, 0320642.
- 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