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
FDA device recall Z-0145-2015 · posted 2014-10-29 · Terminated
Recall details
- Recalling firm
- Parker Laboratories, Inc.
- 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.
- Action taken
- Parker Laboratories Inc. sent an "Urgent Medical Device Product Recall" Letter/Response Form via Fedex to their customers. The letter indentified the affected product, problem and actions to be taken. For questions contact Parker Laboratories Quality Assurance at 973-276-9500, ext. 7142.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 367 boxes
- Distribution
- Worldwide Distribution: US (Nationwide) and country of: Canada.
- Date initiated
- 2014-08-06
- Date posted
- 2014-10-29
- Date terminated
- 2015-04-29
- Location
- Fairfield, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE PROBE COVER (K953673) | Parker Laboratories, Inc. | 1996-03-14 |