Recall Z-0783-2018— Avid Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Avid Medical, Inc., initiated 2017-06-22, terminated 2018-10-12. FDA's recall record names no specific 510(k) clearance for this event. Product: AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09. Reason: Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification..
- Recalling firm
- Avid Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-22
- Terminated
- 2018-10-12
- Firm location
- Toano, VA, United States
Product description
AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
Reason for recall
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.