Recall Z-0145-2015— Parker Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Parker Laboratories, Inc., initiated 2014-08-06, terminated 2015-04-29. It names one FDA 510(k) clearance: K953673. Product: Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.. Reason: Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers..
- Recalling firm
- Parker Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-06
- Terminated
- 2015-04-29
- Firm location
- Fairfield, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
Reason for recall
Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.