Recall Z-0444-2013 ยท MMP Cover, Barrier, Protective
Metrex Research, LLC.
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.
| Date | Nov 27, 2012 (initiated Sep 20, 2011) |
| Status | Terminated |
| Reason | 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). |
| Root cause | 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 ques |
| Quantity | 3,348 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962288 | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER Pinnacle Products, Inc., Jan 30, 1997 |