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U.S. Department of Health and Human Services

Class 2 Device Recall Microcuff

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  Class 2 Device Recall Microcuff see related information
Date Initiated by Firm June 04, 2007
Date Posted August 08, 2007
Recall Status1 Terminated 3 on June 12, 2008
Recall Number Z-1144-2007
Recall Event ID 38226
510(K)Number K050803  
Product Classification Endotracheal Tube - Product Code BTR
Product Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
Code Information Product code: 35162-07, 35162-07, 35163-07 and 35164-07, All lot numbers 
Recalling Firm/
Manufacturer		 Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
For Additional Information Contact Mark L. Bussone
770-587-8393
Manufacturer Reason
for Recall		 The tubes may kink during use which may impede or prevent ventilation.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter sent via overnight mail on/about June 4, 2007. A follow-up letter was sent to consignees via fax on June 5, 2007. Consignees were instructed to cease distributing the product and return all affected product in inventory to Kimberly-Clark. Distributors were instructed to notify their accounts of the recall. A Product Recall Response Sheet (Packing Slip) was attached to the recall notice.
Quantity in Commerce 4376 cases (43760 units/total for both products)
Distribution Worldwide, including USA, Canada, Europe, Australia, Chile, Hong Kong, Singapore, Thailand, India, Malaysia and Saudi Arabia.
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 = BTR and Original Applicant = VITAID, LTD.
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