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Class 2 Device Recall KimberlyClark/Ballard TRACH CARE |
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| Date Initiated by Firm |
November 30, 2005 |
| Date Posted |
January 11, 2006 |
| Recall Status1 |
Terminated 3 on September 06, 2006 |
| Recall Number |
Z-0374-06 |
| Recall Event ID |
34218 |
| Product Classification |
Catheters, Suction, Tracheobronchial - Product Code BSY
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| Product |
Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * 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 8308, Lot number 318065 |
Recalling Firm/
Manufacturer |
Kimberly-Clark Corporation
1400 Holcomb Bridge Rd
Roswell GA 30076
|
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 |
52 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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