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U.S. Department of Health and Human Services

Class 2 Device Recall Busse Suction Instrument with Tubing

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 Class 2 Device Recall Busse Suction Instrument with Tubingsee related information
Date Initiated by FirmApril 13, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on February 18, 2005
Recall NumberZ-0845-04
Recall Event ID 28815
Product Classification Unit, Suction Operatory - Product Code EBR
ProductSuction 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Busse Hospital Disposables
75 Arkay Drive
Hauppauge NY 11788-3707
For Additional Information ContactMs. Carol Doblan
800-645-6526
Manufacturer 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 Determined
Cause 2		Other
ActionUrgent Product Recall Letters and Response Forms were sent to the consignees via Registered Mail on 4/13/04.
DistributionDistributors 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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