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Class 2 Device Recall Pinnacle Cure Sleeve |
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Date Initiated by Firm |
September 20, 2011 |
Date Posted |
November 27, 2012 |
Recall Status1 |
Terminated 3 on November 29, 2012 |
Recall Number |
Z-0444-2013 |
Recall Event ID |
63583 |
510(K)Number |
K962288
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Product Classification |
Cover, barrier, protective - Product Code MMP
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Product |
Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter. |
Code Information |
Part Number Lot Number 4511 201008270110 |
Recalling Firm/ Manufacturer |
Metrex Research, LLC. 28210 Wick Rd Romulus MI 48174-2639
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For Additional Information Contact |
734-946-7800
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Manufacturer Reason for Recall |
The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).
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FDA Determined Cause 2 |
Error in labeling |
Action |
The firm, Sybron Dental Specialties, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 20, 2011 to its consignees/customers. The consignees/customers were instructed to determine if they have any of the affected product in their inventory; if they have the affected product to contact Metrex Research Customer Care at 1-800-841-1428 to receive an RMA number; return any affected product in their inventory; and complete and return the Recall Response Form via mail to: Metrex Research, 29210 Wick Road, Romulus, Michigan 48174, Attn: QA Lab or fax to: 734-947-6725.
If you have any questions regarding this recall, you can contact our Customer Care Center at 1-800-841-1428. |
Quantity in Commerce |
3,348 units |
Distribution |
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. |
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 = MMP and Original Applicant = PINNACLE PRODUCTS, INC.
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