LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
FDA device recall Z-1368-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Quest Medical, Inc.
- Reason for recall
- Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels
- Action taken
- The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HNL
- Quantity affected
- 106 units
- Distribution
- Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.
- Date initiated
- 2015-02-26
- Date posted
- 2015-04-02
- Date terminated
- 2016-02-26
- Location
- Allen, TX
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