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U.S. Department of Health and Human Services

Class 2 Device Recall GS ENDOSCOPY PACK

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 Class 2 Device Recall GS ENDOSCOPY PACKsee related information
Date Initiated by FirmJune 11, 2025
Date PostedAugust 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2249-2025
Recall Event ID 97149
Product Classification General surgery tray - Product Code LRO
ProductGS ENDOSCOPY PACK. Medical convenience kit.
Code Information Model No. NAMC421-10, NAMC421-11, NAMC421-12; UDI: 10809160374597, 10809160417539, 10809160435779; Kit Lot No. 1584375, 1588403, 1605341, 1615427, 1615428, 1627706, 1628153, 1628008, 1628009, 1628647, 1632992.
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
757-566-3510
Manufacturer Reason
for Recall		CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were sent an URGENT: MEDICAL DEVICE FIELD CORRECTION notice, dated 6/11/25, via email. The notification instructs consignees to not use the CLEARIFY Visualization System (component #5303907) and discard. All other components in the kit may be continued to be used. Consignees are to add warning labels to affected procedure trays to ensure the affected component is discarded. The provided Recall Response Form is to be completed and returned to Owens&Minor. Any quality problems or adverse events associated with recalled devices may be reported via email to complaints@owens-minor.com
Quantity in Commerce816 units
DistributionDomestic: CA, IL, MD, OH, PA, TX, WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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