| Class 2 Device Recall Steris Quick Connect (tethered) |  |
Date Initiated by Firm | March 07, 2003 |
Date Posted | February 06, 2003 |
Recall Status1 |
Terminated 3 on February 05, 2004 |
Recall Number | Z-0547-03 |
Recall Event ID |
25374 |
510(K)Number | K875280 |
Product Classification |
Sterilizer, Chemical - Product Code MLR
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Product | C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473. |
Code Information |
Lot nos: 3508686 or smaller (C1406 and QLC1406); Lot nos: 3147303 or smaller (C1473 and QLC1473). |
Recalling Firm/ Manufacturer |
Steris Corp 5960 Heisley Rd Mentor OH 44060
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Manufacturer Reason for Recall | The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle. |
FDA Determined Cause 2 | Other |
Action | On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced. |
Quantity in Commerce | 1,140 units |
Distribution | Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel. |
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 = MLR
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