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Class 2 Device Recall Disposable TearAway Introducer Sets |
 |
| Date Initiated by Firm |
June 06, 2005 |
| Date Posted |
October 21, 2005 |
| Recall Status1 |
Terminated 3 on October 10, 2006 |
| Recall Number |
Z-0065-06 |
| Recall Event ID |
32667 |
| Product Classification |
Endoscope, Neurological - Product Code GWG
|
| Product |
Remington Medical, Inc. Ten Disposable Tear-Away Introducer Sets Size 7 French, Sterile: Single Use/Disposable Radiopaque Contents Ethylene Oxide Sterilized. |
| Code Information |
Lot No. 040508, 041111, 042116, 042367, 043146, 050077, 041464 |
Recalling Firm/
Manufacturer |
Remington Medical Inc.
6830 Meadowridge Ct
Alpharetta GA 30005-2202
|
| For Additional Information Contact |
Maria Granito
800-989-0057
|
Manufacturer Reason
for Recall |
The Tear-Away introducer sheath in the Disposable Tear-Away Vascular Introducer kits may exhibit cracked hubs/handles and/or improper peeling of the sheath during use.
|
FDA Determined
Cause 2 |
Other |
| Action |
A recall letter was sent to each consignee July 6th through July 11, 2005 requesting that they examine any product on hand. The letter also indicated that a representative would be contacting them in follow-up to the letter. |
| Quantity in Commerce |
3180 units |
| Distribution |
AL, AR, CA, CO, FL, GA, IN, IA, MD, MN, MO, NE, NV, NY, OH, OK, OR, PA, RI, TX, UT, VA, WA, WI |
| 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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