| | Class 2 Recall
Pinnacle Cure Sleeve |  |
| Date Posted |
November 27, 2012 |
| Recall Number |
Z-0444-2013 |
| 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 |
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).
|
| 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. |
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