| Class 2 Device Recall KimberlyClark/Ballard TRACH CARE | |
Date Initiated by Firm | November 30, 2005 |
Date Posted | January 11, 2006 |
Recall Status1 |
Terminated 3 on September 06, 2006 |
Recall Number | Z-0375-06 |
Recall Event ID |
34218 |
Product Classification |
Catheters, Suction, Tracheobronchial - Product Code BSY
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Product | Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA |
Code Information |
Catalog number 8213, Lot Number 309962 |
Recalling Firm/ Manufacturer |
Kimberly-Clark Corporation 1400 Holcomb Bridge Rd Roswell GA 30076
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Manufacturer Reason for Recall | The integrity of the sterile unit package may become compromised. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified via certified mail, return receipt on 11/30/2005. The neonatal recall was faxed to the two consignees with a method to return product. |
Quantity in Commerce | 25 cases (20 units per case) |
Distribution | AL, AZ, CA, CO, FL, GA, IA, IL, KY, MD, MO, MN, NJ, NY, OH, OK, PA, RI, SD, TN, TX, UT, VA, WV, WY. |
Total Product Life Cycle | TPLC Device Report |
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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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