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U.S. Department of Health and Human Services

Class 2 Device Recall Steriseal BiManual Irrigating/Aspirating Handpiece

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  Class 2 Device Recall Steriseal BiManual Irrigating/Aspirating Handpiece see related information
Date Initiated by Firm March 02, 2015
Date Posted June 19, 2015
Recall Status1 Terminated 3 on May 13, 2016
Recall Number Z-1820-2015
Recall Event ID 70675
Product Classification Cannula, ophthalmic - Product Code HMX
Product Steriseal-Cannula Ophthalmic;

Bi-Manual Irrigating/Aspirating Handpiece.
Code Information Product #s: 157400; 257400; 157500; 257500
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Lynda McConagh
812-934-7777
Manufacturer Reason
for Recall		 The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
FDA Determined
Cause 2		 Use error
Action Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.
Quantity in Commerce 66691 units
Distribution Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
Total Product Life Cycle TPLC Device Report
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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