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U.S. Department of Health and Human Services

Class 2 Device Recall TLS Surgical Drainage System

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  Class 2 Device Recall TLS Surgical Drainage System see related information
Date Initiated by Firm January 03, 2017
Date Posted February 08, 2017
Recall Status1 Terminated 3 on July 27, 2017
Recall Number Z-1149-2017
Recall Event ID 76146
510(K)Number K833586  
Product Classification Apparatus, suction, single patient use, portable, nonpowered - Product Code GCY
Product QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile)
SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)

Accessories to TLS Surgical Drainage System
Code Information Part # 6630 QUINTUBE Monitor Pack Lots-  M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M1309007, M1309008, M1309009, M1309010, M1607009, M1607010, T1309003  Part # 6649 SPG Bulb Drain System, 4mm Flat w/Center Holes Lot - M1508003
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Strasse 41
Freiburg Germany
For Additional Information Contact
800-962-6558
Manufacturer Reason
for Recall		 An incorrect sterility status on the label, non-sterile products labeled as sterile
FDA Determined
Cause 2		 Labeling mix-ups
Action Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.
Quantity in Commerce 619
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = GCY and Original Applicant = POREX MEDICAL
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