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U.S. Department of Health and Human Services

Class 2 Device Recall Pinnacle Cure Sleeve

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 Class 2 Recall
Pinnacle Cure Sleeve
see related information
Date Posted November 27, 2012
Recall Status1 Terminated on November 29, 2012
Recall Number Z-0444-2013
Recall Event ID 63583
Premarket Notification
510(K) Number
K962288 
Product Classification Cover, Barrier, Protective - Product Code MMP
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, Michigan 48174-2639
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).
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = PINNACLE PRODUCTS, INC.
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