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.
Recall
- Recall Number
- Z-0444-2013
- Event Number
- 63583
- Firm
- Metrex Research, LLC.
- FEI Number
- 1000117344
- Product Code
- MMP
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- September 20, 2011
- Posted
- November 27, 2012
- Terminated
- November 29, 2012
- Address
- 28210 Wick Rd, Romulus, MI, 48174-2639
Description
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.
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).
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.
Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.
3,348 units