Date Initiated by Firm | April 27, 2005 |
Date Posted | June 25, 2005 |
Recall Status1 |
Terminated 3 on June 27, 2005 |
Recall Number | Z-0932-05 |
Recall Event ID |
32022 |
510(K)Number | K042461 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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Product | Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case. |
Code Information |
158125 and 158128 |
Recalling Firm/ Manufacturer |
Kendall Healthcare Products Co 15 Hampshire St Mansfield MA 02048-1113
|
For Additional Information Contact | Marcus Gesner 508-261-6652 |
Manufacturer Reason for Recall | Holes in thermoformed tray compromising the sterility of the product. |
FDA Determined Cause 2 | Other |
Action | Visits by Tyco Sales Reps on 4/27 & 28/2005. |
Quantity in Commerce | 120 units |
Distribution | Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX. |
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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510(K) Database | 510(K)s with Product Code = LJS
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