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 pa Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 pa
Brand
Busse Hospital Disposables
Lot Codes / Batch Numbers
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.
Products Sold
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.
Busse Hospital Disposables is recalling Suction Instrument with Tubing, Catalog No. 302. Instrument: Yankauer without Vent. *Tubing: 6'' x 1 due to Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PV. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026