Recall Z-0444-2013— Metrex Research, LLC.

Name: FDA recall Z-0444-2013
Creator: U.S. Food and Drug Administration
Published: 2011-09-20

Class II · Terminated

Class II FDA medical device recall by Metrex Research, LLC., initiated 2011-09-20, terminated 2012-11-29. It names one FDA 510(k) clearance: K962288. 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.. 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)..

Recalling firm: Metrex Research, LLC.
Classification: Class II
Status: Terminated
Initiated: 2011-09-20
Terminated: 2012-11-29
Firm location: Romulus, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K962288 — COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVERPinnacle Products, Inc.·cleared 1997-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.